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Temporomandibular Lavage Versus Nonsurgical Treatments for Temporomandibular Disorders: A Systematic Review and Meta-Analysis
Accepted Manuscript Temporomandibular lavage versus non-surgical treatments for temporomandibular disorders: A systematic review and meta-analysis Carl Bouchard, DMD, MSc, FRCD(C), Jean-Paul Goulet, DDS, MSD, Mehdi ElOuazzani, DMD, Alexis Fournier-Turgeon, MD, MSc (Epid.), FRCPC PII:
S0278-2391(16)31315-5
DOI:
10.1016/j.joms.2016.12.027
Reference:
YJOMS 57589
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 23 October 2016 Revised Date:
28 November 2016
Accepted Date: 12 December 2016
Please cite this article as: Bouchard C, Goulet J-P, El-Ouazzani M, Fournier-Turgeon A, Temporomandibular lavage versus non-surgical treatments for temporomandibular disorders: A systematic review and meta-analysis, Journal of Oral and Maxillofacial Surgery (2017), doi: 10.1016/ j.joms.2016.12.027. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Temporomandibular lavage versus non-surgical treatments for temporomandibular disorders: A systematic review and metaanalysis
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Carl Bouchard, DMD, MSc, FRCD(C)1, 4; Jean-Paul Goulet, DDS, MSD2; Mehdi El-Ouazzani, DMD1, Alexis Fournier-Turgeon, MD, MSc (Epid.), FRCPC3 1
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Centre Hospitalier Universitaire (CHU) de Québec Université Laval Hôpital de l'Enfant-Jésus 1401, 18e rue Québec (Québec), Canada G1J 1Z4 Tel: 418-265-8744 Fax: 418-624-3338
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Associate professor, department of Oral and maxillofacial surgery - CHU de Québec – Université Laval (Hôpital de l’Enfant-Jésus), Québec (Québec), Canada 2 Resident, school of dental medicine, Université Laval, Québec (Québec), Canada 3 Associate professor, Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, and Université Laval Research Center, Population Health and Optimal Health Practices Unit (Trauma - Emergency - Critical Care Medicine), Québec (Québec), Canada 4 Corresponding author
[email protected]
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Conflict of interests: none Funding: none
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Key words: temporomandibular joint; arthroscopy; arthrocentesis, temporomandibular disorders; pain; mouth opening; lavage
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Abstract Purpose: To investigate the efficacy of temporomandibular joint (TMJ) lavage (arthrocentesis or arthroscopy) for
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the treatment of temporomandibular disorders (TMDs) in reducing pain and improve jaw motion.
Patients and methods: We performed a systematic review of the literature and meta-analysis of randomized-
controlled trials (RCT) comparing TMJ lavage to conservative measures. Data sources were MEDLINE, EMBASE, CENTRAL (Cochrane), Scopus and Web of Science and reference lists of relevant articles. Two independent
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reviewers identified RCTs by using controlled vocabulary (MeSH, Emtree) and free text terms. Data extracted from the selected studies were: population characteristics, intervention, outcomes and funding sources. Risk of bias was
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assessed using the Cochrane collaboration risk assessment tool for RCTs.
Results: Five studies met inclusion criteria, for a total of 308 patients. Three studies were categorized as having a high risk of bias and 2 had a low risk. The summary effect of the five studies showed a reduction in pain in the intervention group at 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001, I2 = 88%) and 3 months (-0.47, 95% CI [0.75, -0.19], p = 0.001, I2 = 85%). This was not the case at 1 month. No difference in mouth opening was observed
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at 6 months (-0.21, 95% CI [-1.82, 1.40], p < 0.80, I2 = 74%), 3 months (0.20, 95% CI [-1.81, 2.20], p = 0.85, I2 = 68%) and 1 month (-1.18, 95% CI [-2.90, 0.55], p = 0.18, I2 = 0%).
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Conclusion: Giving the relatively small number of patients included in this meta-analysis, the high risk of bias in 3 studies and the statistical and clinical heterogeneity of the included studies, the use of TMJ lavage for the treatment
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of TMDs should be recommended with cautions giving the lack of strong evidence to support its use.
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Introduction
Temporomandibular disorders (TMDs) are a heterogeneous group of musculoskeletal conditions affecting temporomandibular joints (TMJ), masticatory muscles and surrounding facial structures that can result in pain and
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limitation of jaw function.1 Not surprisingly, the etiology of TMDs can be quite varied and known causes include developmental, trauma, infection, autoimmune and neoplasms. However, the etiology of the most frequently seen muscle and joint disorders in clinic is at best speculative and factors that are frequently held as responsible for pain and dysfunction comprise bruxism, clenching, stress, malocclusion and estrogen imbalance in female patients. The
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often solicited during daily activities such as chewing and speaking.
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symptoms experienced by patients with a joint disorder can have a negative effect on their quality of life as TMJs are
Nonsteroidal anti-inflammatory drugs, muscle relaxants, splint therapy and physical therapy are usually used as the first line of treatment. Surgical interventions are contemplated when conservative and reversible treatments fail to relieve the patients’ symptoms and severe disability persists.2 TMJ lavage is a non-invasive procedure involving the irrigation of the upper joint space with isotonic saline solution.3, 4 It can be performed simply with two needles and
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an irrigation circuit (arthrocentesis) or with the use of an arthroscope (arthroscopy). The later technique was described by Ohnishi in 1975 and allows visualization of the structures of the upper joint space, but the potential therapeutic effect of both procedures have been demonstrated to be similar; therefore, they were considered as one
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intervention for the purpose of this research.5-7
In 2013, Vos et al. performed a systematic review (SR) of lavage therapy versus non-surgical treatment for arthralgia of the TMJ and concluded that lavage may be more effective, but only 3 randomized controlled studies were
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retained.8 Two of the studies had a high risk of bias and only a total of 85 patients received the intervention (TMJ lavage). Guo et al. did a SR on TMJ lavage in 2009, but they included studies with surgical procedures as the comparators.7 Because it appears that the current literature does not provide a clear answer on the potential efficacy of TMJ lavage, and no new randomized controlled trials (RCT) were published since the last SR by Vos et al. (2013), we decided to conduct a new SR of RCTs. The objective of the present SR is to evaluate the efficacy of TMJ lavage compared to non-surgical intervention by systematically searching the literature for studies assessing TMJ pain and function.
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Methods/design :
This SR was conducted in conformity with the Cochrane Collaboration principles for Systematic Reviews.9 The
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results obtained are reported according to PRISMA guidelines. The full peer-reviewed search strategy and research protocol defining eligibility criteria, selection process and data extraction were completed during the planning phase.
Databases, search terms and strategies:
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MEDLINE, EMBASE, CENTRAL (Cochrane), Scopus and Web of Science were searched up to May 1st, 2016 using controlled vocabulary (MeSH, Emtree) and free text terms. In addition the search included the International Clinical
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Trials Registry Platform (ICTRP) to identify ongoing studies. The search strategy was developed for MEDLINE (OVID) and modified accordingly to the database reviewed (see Appendix 1). The reference list of all included trials and previous narrative and systematic reviews were searched. There were no restrictions regarding the date of publication. Reference management used EndNote (Version X7, Thomas Reuters).
Studies were included if:
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Inclusion/exclusion criteria
1- they were randomized-controlled trials for the treatment of TMJ pain
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2- the intervention was TMJ lavage with needles (athrocentesis) alone or with the use of an arthroscope 3- the comparator was nonsurgical treatment
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4- the primary outcome was the reduction of pain 5- the secondary outcomes was one or more of the following: jaw function based on mouth opening, improvement in chewing abilities; improvement of quality of life; adverse effect of the procedure.
Studies were excluded if: 1- they were conducted on animals
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Study selection:
After the database search two authors (CB, MEO) read all the titles and abstracts to identify potentially eligible articles meeting the inclusion criteria. Articles without an abstract but with a title suggesting they could meet the
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inclusion criteria were kept to the next step. The full text of selected studies was retrieved and reviewed by 2 authors (CB, MEO). All studies fulfilling the inclusion criteria were retained for data extraction.
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Data extraction:
An Excel table for data extraction was built a priori to the review process. This table was tested on 2 selected
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studies to ensure that all relevant data could be extracted. The data extracted from the selected studies were the following:
Study characteristics: title, authors, journal/source, years and language of publication, country, type of study, study period, total number of patients, inclusion/exclusion criteria, randomization, allocation concealment, founding
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sources.
Sample characteristics: Age, sex, TMD diagnosis, follow-up duration and comorbidities. Interventions: Arthroscopy or arthrocentesis, type of medication infiltrated, analgesics. Comparator: type of intervention in the control group (placebo, no intervention, physiotherapy, etc.)
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Risk of bias
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Outcomes: all outcomes reported, including adverse events.
The risk of bias was assessed using the Cochrane collaboration risk assessment tool for RCTs.9 For each study, the following items were assessed for “low”, “high” or “unclear” risk of bias: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other biases.
Statistical analysis
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Review Manager (RevMan, version 5.3, the Nordic Cochrane Center, the Cochrane Collaboration) was used to analyze the data. Pain assessment (on a visual analog scale at rest or during movement) and mouth opening were reported as continuous variables with standard deviation (SD); therefore, the pooled effect of the intervention is
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reported as difference in means with 95% confidence interval (CI). A standardized mean difference was utilized for pain as the measurement scale varied across studies. Difference between groups was calculated using final value scores, not change-from-baseline scores, because the later data were not available for most studies. Evaluation of heterogeneity was calculated with I2 statistics. This test estimates the percentage of variation between study results
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that is due to heterogeneity rather than sampling error. Fixed effects model was favored because of the limited number of studies eligible (<5) and to avoid overpowering the results of smaller studies. We performed subgroup
potential sources of heterogeneity.
Results
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analyses for initial diagnosis and type of intra-articular medication injected at the time of TMJ lavage to find out
Our search strategy yielded a total of 3492 citations after removal of duplicates. After initial screening of the title and
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abstract ten articles were fully retrieved in full text and reviewed for eligibility. Of these 5 articles met the inclusion criteria (Figure. 1). Three studies were excluded because there was no randomization. The other two were studies reporting on the same cohort of patients with the same results published twice in 2 different journals. Schiffman et
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al. first reported in 2007 a RCT on the efficacy of four treatment strategies for TMD.10 The same study was also published in 2014, but using different outcome measures.1 The risk of bias was assessed with the later study because
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the method section was more explicit, but the results were extracted from the 2007 publication because specific values for pain intensity and maximal mouth opening are reported. A summary of the included studies is presented in table 1.
Individual study characteristics
Vos et al. compared arthrocentesis to conservative management (stepwise approach using soft diet, physical therapy,
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splint therapy) in a parallel group RCT.11 Patients with TMJ pain not responding to 2 weeks of non-steroidal antiinflammatory treatment were subjected to local anesthesia of the affected TMJ and randomized to either arthocentesis or usual conservative care if the anesthesia completely relieved their joint pain. Forty patients were
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randomized in each group after sample size calculation. Mean age of the patients in the intervention group (29 females) was 38.3 years (SD 15.9) and 36.1 years (SD 14.3) in the control group (31 females). Maximum active mouth opening (MMO) and pain at rest and during maximum mouth opening were the primary outcomes and were measured at baseline, 3 (T1), 12 (T2) and 26 (T3) weeks. Pain was assessed on a 0-100 mm visual analog scale
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(VAS). The examiner proceeding to the data collection was ignorant of the treatment allocation, but patient were not blinded to the intervention. Four patients dropped out in each group. Patients not showing at follow-up T1, T2 and
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T3 were respectively in the intervention and control group 2/4, 4/3 and 9/6. Because the results are presented with figures, the authors were contacted and they provided numerical data for VAS and MMO.
Schiffman et al. first published a RCT comparing 4 treatment strategies for TMJ closed lock in 2007.10 With the same data set the authors reassessed the effectiveness of the four treatment using outcome measures recommended by the International Association of Oral and Maxillofacial Surgeons in a paper published in 2014.1 A stratified
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randomization process was employed by dividing patients in two strata, depending if they had chronic disorder (> 6 months of limited mouth opening) or not (< 6 months). Unequal blocks of randomization were created because they anticipated that more patients would prefer medical management to other treatments. All patients had a magnetic
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resonance diagnosis of Wilkes’s stage III or IV closed lock. Twenty-nine patients (26 females, mean age 33.7 years, SD 1.8) were randomized in the medical management group (patient education, optimistic counseling, self-help
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program, systemic corticosteroids for 6 days followed by NSAIDS for up to 6 weeks), 25 patients (25 females, mean age 30 years, SD 1.7) received rehabilitation (medical management as described plus stabilization splints, physical therapy and cognitive behavioral therapy), 26 patients (22 females, mean age 31.8 years, SD 1.7) underwent arthroscopic surgery that included intracapsular injection of betamethasone and 26 patients (25 females, mean age 31.4 years, SD 1.9) had an arthroplasty (disc repositioning procedures when feasible or disc removal). An intention to treat analysis was employed so patients receiving additional therapy were evaluated according to their original treatment. Ten patients withdrew after randomization. Eight patients missed the 6-month follow-up (1 in the medical management group, 3 in rehabilitation group, 2 in the arthroscopic surgery group and 2 in the arthroplasty group).
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The primary outcome was the craniomandibular index and the modified symptom severity index and they were measured by an examiner blinded to the treatment at 3, 6, 12, 18, 24 and 60 months. Results of pain intensity and MMO were not published in this study, but were reported in a previous systematic review after the authors were
at 1 and 3 months, but no additional results were provided.
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contacted.8 These results were utilized in our meta-analysis. We also contacted the authors to obtain MMO and VAS
Sahlström et al. recruited 45 patients to participate in a single-blind RCT evaluating the short-term efficacy of local
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anesthesia and arthrocentesis compared to a control intervention limited to local anesthesia alone for the treatment of TMJ arthralgia of at least three months duration coupled with a diagnosis of disc displacement without reduction.12
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Both the control and intervention group received a premedication with 1000 mg paracetamol per os and received local anesthesia in the area of the TMJ (auriculotemporalis block) in preparation of a lavage treatment. The control group was then subjected to a simulated lavage procedure (saline was injected in a cup hidden from the patient after the installation of the drape) while the treatment group received a full lavage procedure with 50 ml of saline. Both groups were prescribed paracetamol 1000 mg for 3 days as needed. Randomization was performed using a table of random sampling numbers. An examiner not involved in the treatment of participants was responsible for this
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process. Similarly, patients were evaluated for pain and MMO at baseline, 1 and 3 months by a blinded examiner. Pain intensity was measured at rest and during movement with a 0-100 mm VAS. Maximum unassisted mouth opening without pain, maximum unassisted mouth opening and assisted maximum mouth opening were measured.
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Twenty patients (18 females, mean age 34.1 years, SD 12.6) underwent lavage and 25 (23 females, mean age 35.6 years, SD 15.6) had local anesthesia with simulated lavage. The number of patients was determined after sample
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size calculation. Eight patients withdrawn (6 in the intervention group) of the study because they received rescue treatment. Data up to that point were utilized to perform an intention-to-treat analysis.
Diraçoğlu et al. treated 120 patients (104 female) with non-reducing disk with either arthrocentesis or non-surgical treatment (stabilization splint day and night for 6 months except during eating and tooth brushing, heat packs daily for 10 days, home exercise programs for jaw muscle and range of motion).13 Patients with symptoms duration for a maximum of 3 weeks were allocated to one of the treatment groups alternatively as they were admitted to their multidisciplinary TMJ unit. Outcomes measured by a blinded examiner were pain measured on a 0-10 cm VAS and
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MMO at baseline, 1, 3 and 6 months. Ten patients were lost to follow up, leaving 54 individuals (51 females, mean age 33.4, ranges 15-63) in the intervention group and 56 (49 females, mean age 34.8, ranges 17-61) in the non-
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surgical group.
Stegenga et al. performed a RCT comparing arthroscopic surgery to physical therapy or no treatment for patients with TMJ pain and jaw movement limitation.14 A total of 28 patients were randomized to either one of the treatment groups. After 2 weeks of conservative treatment (exercises, soft diet, explanation), 7 patients were excluded because
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they were asymptomatic, leaving 21 patients (mean age 23.7, DS 6.7, ranges 17-41) to participate in the study (9 arthroscopic surgery, 12 conservative treatment). All patients in the arthroscopic surgery group had lavage of the
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joint space and either lysis of adhesion, disk mobilization, lateral release, coagulation of tissues or a combination of these. They also underwent physical therapy postoperatively. Pain intensity measured on a 0-100 mm VAS and MMO were evaluated at 1 and 6 months.
Risk of bias across studies
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A summary of the risk of bias analysis is presented in figure 2. Two studies were at low risk of bias (Schiffman et al., Vos et al.) and 3 were at high risk (Stegenga et al., Sahlström et al., Diraçoğlu et al.). Stegenga et al. did not report the method of randomization and Diraçoğlu et al. used an alternation method to assign patients in each group.
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Blinding of participants was not possible in most studies because the intervention was a surgical procedure. Examiners were not blinded in Diraçoğlu et al. and Stegenga et al. studies and this was considered a high risk of bias,
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giving the primary outcome was measurement of pain. A high risk attrition bias was observed in Sahlström et al. study due to the loss of 6/20 patients in their intervention group, compared to 2/25 in the control group. However, even if there were 3 times more dropouts between the first and third-month follow-up in the intervention group, it is doubtful that the conclusion of the study would have changed since all subjects dropping out underwent rescue treatment because of no improvement.
Results of individual studies
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Vos et al. observed a comparable decrease for pain at rest and with MMO, and improvement in MMO in both groups at 26 weeks (no p-values reported).11 Generalized estimated equations multivariate models demonstrated a significant difference between arthrocentesis and conservative treatments, showing that patients in the first group improved
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more rapidly (β coefficient for pain at rest: -11.42, 95% confidence interval -16.34, -6.50, p = 0.000; β coefficients for MMO: -2.70, confidence interval -5.35, -0.06, p = 0.045). Overtime, both treatments showed similar results.
Schiffman et al. reported in the 2007 study no significant improvement in pain (e.g. usual level of pain in the past
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month) (p = 0.14) and MMO (p = 0.52) after arthroscopy compared to non-surgical treatment (medical management and rehabilitation) at 6 months.10 No significant difference between groups at 3 (p = 0.23) and 6 months (0.083) was
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noted on the symptom severity index and self-measured pain index. Similarly, no differences between treatment groups were seen with the new outcomes reported in 2014 by the same authors as the original report.1
Sahlström et al. found a 30% pain reduction in 56% of the patients who received local anesthesia alone compared to 40% in the lavage group at 1 month (p = 0.286).12 At 3 months, corresponding numbers were respectively 76 and 55% (p = 0.138). Pain at rest and during jaw motion at 1 and 3 months did not differ significantly between groups (p
received.
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= 0.986 and p = 0.124 respectively). No significant difference was found for MMO, independent of the treatment
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Diraçoğlu et al. observed a significant improvement in pain (unspecified if pain at rest or with jaw motion or at MMO) with arthrocentesis compared to non-surgical treatment at 3 months (p = 0.01) and 6 months (p = 0.01). 13
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This was not the case at one month. MMO did not differ significantly at any time point between groups.
Stegenga et al. did showed a statistically significant difference in pain (TMJ pain at rest) between treatment groups based on subjective assessment evaluation at 1 and 6 months (p < 0.01).14 The same could not be demonstrated for jaw movement. Baseline pain intensity was significantly higher in the arthroscopic group compared to the control group (p < 0.05).
Synthesis of results
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Pain Pooled standardized mean difference for the reduction of pain between intervention and control showed a significant advantage for lavage at 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001, I2 = 88%) (Figure 3). This was also the
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case at 3 months (-0.47, 95% CI [-0.75, -0.19], p = 0.001, I2 = 85%), but not at 1 month (-0.13, 95% CI [-0.38, 0.13], p = 0.36, I2 = 9%)(Figures 4 and 5). Subgroup analysis showed that patients with TMJ closed lock had less pain at 6 months after lavage (-0.76 [-1.09, -0.44], p = 0.0000, I2 = 95%). The difference was not significant at any other time
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points. The injection of corticosteroids had no significant effect on pain (Table 2).
Mouth opening
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Pooled standardized mean difference for maximum mouth opening showed no difference between groups at 6 months (-0.21, 95% CI [-1.82, 1.40], p < 0.80, I2 = 74%), 3 months (0.20, 95% CI [-1.81, 2.20], p = 0.85, I2 = 68%) and 1 month (-1.18, 95% CI [-2.90, 0.55], p = 0.18, I2 = 0%) (Figures 6, 7 and 8). The subgroup analysis showed a significant reduction in mouth opening in the control group at 1 (-2.92 [-5.73, - 0.10], p = 0.04, I2 = 0%) and 6
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months (-3.28 [-5.88, -0.69], p = 0.01, I2 = 46%) when the diagnosis was not specifically a closed lock (Table 3).
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Discussion
This systematic review of TMJ lavage versus conservative measures identified 5 studies that met inclusion criteria.
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All were randomized10-12, 14 or quasi-randomized13 controlled trials. The only quasi-randomized trial had the largest sample of patients.13 TMJ lavage was superior to the control for the reduction of pain at 3 (-0.47, 95% CI [-0.75, 0.19], p = 0.001) and 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001). We did not show the superiority of the intervention for improvement in mouth opening at any time point (1 month: p = 0.18; 3 months: p = 0.85; 6 months:
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p > 0.80).
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These results have to be interpreted with caution, as there was a high risk of bias in 3 of the studies, including the one with the largest sample.12-14 There was no blinding of the examiner in one of the studies.12 This was considered a high risk of bias, as the primary outcome measured was pain. The overall sample size was relatively small (intervention: 135, control: 173) and one study only had 21 patients.14 Many patients across the studies were lost to follow up at different time points and only 2 studies adhered to an intention-to-treat protocol.10, 11 Substantial statistical heterogeneity at the 3 and 6 months analysis (I2 > 60%) was observed for both outcomes. There is also
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clinical heterogeneity between studies, as patients in the intervention and control group received different treatment modalities. Also, some patients had more acute diseases13 and other more chronic conditions with long-term pain and degenerative changes10, 12, 14. We performed a subgroup analysis comparing patients with closed lock (3 citations)10, to patients with an unspecified diagnosis (2 citations)11, 14 and found that lavage was more efficacious in
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12, 13
reducing pain at 6 months. However, there were certainly patients with closed lock in the two studies with
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unspecified diagnosis.
Vos et al. reported similar results in a meta-analysis published in 2013.8 At 6 months, they observed a reduction in mean standardized differences for pain (- 1.07 [-1.38, -0.76), but not for MMO (-0.05 [-0.33, 0.23]). The 3 studies utilized for their SR were also retained in this research. They did not report pool effect at 1 and 3 months. A Cochrane collaboration review published by Guo et al. in 2009, included only 2 studies and concluded that there was insufficient data to either support or refute the use of TMJ lavage for the treatment of TMDs.7 It was recently withdrawn because it did not meet their current methodological standards.15 Murakami et al. enrolled 108 patients to
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participate in a prospective non-randomized clinical trial with 3 treatment arms: arthroscopy, arthrocentesis and non surgical.16 Patients improved significantly within each group, but the difference between treatments was not significant for pain and jaw motion. Kurita et al., compared arthroscopy to nonsurgical treatment in a prospective
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case-control study with the primary outcome being changes of the articular components of the TMJ (disc displacement, position, morphology, mobility, and degenerative change of the condyle) on magnetic resonance imaging.17 They also reported on patients’ satisfaction with treatment outcomes and observed that there were
significantly more patients (3/9 patients, p < 0.05) in the arthroscopic group with residual symptoms than in the
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control group. However, because patients were not randomized, it is likely that the ones who underwent surgical treatment had more severe conditions preoperatively. Goudot et al. reported a large prospective study involving 708
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patients with a variety of TMDs.6 All received 6 months of conservative measures. Patients still symptomatic after this period (n = 62, 8.8%) were assigned either to arthroscopy (33) or arthrocentesis (29). Of the 62 patients, 11 (18%) had no effect, 11 noted improvement and 40 (64%) had a complete elimination of pain. They also noted that arthroscopy was more effective than arthrocentesis to improve jaw motion. This was explained by the fact that arthroscopies were performed under general anesthesia, allowing more stretching and manipulations.
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There is no consensus on the benefits to inject intra-articular medications (corticosteroids, opioids, hyaluronic acid, etc.) at the end of a lavage procedure. We performed a subgroup analysis to evaluate the efficacy of intra-articular corticosteroids injection and it showed no effect on pain and mouth opening. This is similar to what Olgen-Bergem
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and Bjomland observed in a cohort study on patients with juvenile idiopathic arthritis.18 Thirty joints were treated either with arthrocentesis alone (n = 17) or with the injection triamcinolone hexacetonide (n = 21). Pain and
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function was evaluated at 3 and 8 months and was improved at both time points but there were no differences between treatment groups.
This systematic review with meta-analysis has the largest sample of patients ever reported. With the data available, we were able to perform analysis based on different postoperative follow up time (1, 3 and 6 months). This was never published in a meta-analysis before. Also, we followed a strict research protocol for study selection and risk of bias assessment. All major databases were reviewed, making it unlikely that eligible study were not identified. Limitations of this report include the clinical and statistical heterogeneity of the results and the high risk of bias for
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most of the studies retained. The preoperative diagnosis also varied among studies.
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Conclusion Although we demonstrated a beneficial effect of TMJ lavage on the reduction of pain at 3 and 6 months, the pooled effect on the reduction of pain remains minimal and may not by clinically significant. Before suggesting this
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procedure to patients, clinicians need to take into consideration that nonsurgical treatment may offer similar results, without the risk of complications. It appears that more RCTs comparing TMJ lavage compared to no intervention or placebo need to be implemented.
Legend
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Figure 1: Flow chart of the study selection
Figure 2: Summary of the risk of bias for each study (+ : low risk; - : high risk; ? : unclear risk)
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Figure 3: Forrest plot for the reduction of pain between lavage and conservative methods at 6 months Figure 4: Forrest plot for the reduction of pain between lavage and conservative methods at 3 months Figure 5: Forrest plot for the reduction of pain between lavage and conservative methods at 1 month Figure 6: Forrest plot for the increase in mouth opening between lavage and conservative methods at 6 months Figure 7: Forrest plot for the increase in mouth opening between lavage and conservative methods at 3 months
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Figure 8: Forrest plot for the increase in mouth opening between lavage and conservative methods at 1 month
Table 1: Characteristics of individual trials
Table 2: Subgroup analysis on the reduction of pain
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Table 3: Subgroup analysis on improvement in maximum mouth opening
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Schiffman EL, Velly AM, Look JO et al.: Effects of four treatment strategies for temporomandibular joint closed lock. Int J Oral Maxillofac Surg 2014;43:217 Wilkes CH: Surgical treatment of internal derangements of the temporomandibular joint. A long-term study. Arch Otolaryngol Head Neck Surg 1991;117:64 Nitzan DW, Dolwick MF, Heft MW: Arthroscopic lavage and lysis of the temporomandibular joint: A change in perspective. Journal of Oral and Maxillofacial Surgery 1990;48:798 Al-Belasy FA, Dolwick MF: Arthrocentesis for the treatment of temporomandibular joint closed lock: a review article. International Journal of Oral and Maxillofacial Surgery 2007;36:773 Ohnishi M, Mizutani Y, Ishibashi K et al.: [Diagnostic application of arthroscope to ankylosis of the temporomandibular joint: report of two cases (author's transl)]. Nippon Koku Geka Gakkai Zasshi 1976;22:436 Goudot P, Jaquinet AR, Hugonnet S et al.: Improvement of pain and function after arthroscopy and arthrocentesis of the temporomandibular joint: A comparative study. Journal of Cranio-Maxillofacial Surgery 2000;28:39 Guo C, Shi Z, Revington P: Arthrocentesis and lavage for treating temporomandibular joint disorders. Cochrane Database Syst Rev 2009, CD004973 Vos LM, Huddleston Slater JJ, Stegenga B: Lavage therapy versus nonsurgical therapy for the treatment of arthralgia of the temporomandibular joint: a systematic review of randomized controlled trials. J Orofac Pain 2013;27:171 Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from http://www.cochranehandbook.org. Schiffman EL, Look JO, Hodges JS et al.: Randomized effectiveness study of four therapeutic strategies for TMJ closed lock. Journal of Dental Research 2007;86:58 Vos LM, Huddleston Slater JJ, Stegenga B: Arthrocentesis as initial treatment for temporomandibular joint arthropathy: a randomized controlled trial. J Craniomaxillofac Surg 2014;42:e134 Sahlstrom LE, Ekberg EC, List T et al.: Lavage treatment of painful jaw movements at disc displacement without reduction. A randomized controlled trial in a short-term perspective. International Journal of Oral & Maxillofacial Surgery 2013;42:356 Diracoglu D, Saral IB, Keklik B et al.: Arthrocentesis versus nonsurgical methods in the treatment of temporomandibular disc displacement without reduction. Oral Surgery Oral Medicine Oral Pathology Oral Radiology & Endodontics 2009;108:3 Stegenga B, de Bont LG, Dijkstra PU, Boering G: Short-term outcome of arthroscopic surgery of temporomandibular joint osteoarthrosis and internal derangement: a randomized controlled clinical trial. British Journal of Oral & Maxillofacial Surgery 1993;31:3 Guo C, Shi Z, Revington P: WITHDRAWN: Arthrocentesis and lavage for treating temporomandibular joint disorders. Cochrane Database Syst Rev 2015, CD004973 Murakami K, Hosaka H, Moriya Y et al.: Short-term treatment outcome study for the management of temporomandibular joint closed lock. A comparison of arthrocentesis to nonsurgical therapy and arthroscopic lysis and lavage. Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics 1995;80:253 Kurita H, Chen Z, Uehara S et al.: Comparison of Imaging Follow-Up Between Joints With Arthroscopic Surgery (Lysis and Lavage) and Those With Nonsurgical Treatment. Journal of Oral and Maxillofacial Surgery 2007;65:1309 Olsen-Bergem H, Bjornland T: A cohort study of patients with juvenile idiopathic arthritis and arthritis of the temporomandibular joint: outcome of arthrocentesis with and without the use of steroids. Int J Oral Maxillofac Surg 2014;43:990
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1.
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Intervention
2014
RCT
Low
38.3 (15.9)
Vos et al.
Month
Baseline/post treatment VAS (SD)*
Baseline/post treatment MMO (SD)
1
34
19.27 (21.51) / 11.79 (17.55)
34.66 (8.24) / 36.46 (6.4)
Sahlström et al.
2007
RCT
Low
3
32
19.27 (21.51) / 10.72 (17.36)
34.66 (8.24) / 39.81 (6.4)
6
27
19.27 (21.51) / 6.70 (16.96)
34.66 (8.24) / 41.78 (5.66)
N/A
N/A
RCT
High
6.8 (2.1) / 3.3 (2.2)
33.4 (7.6) / 41.0 (8.2)
1
20
39.5 (29.58) / 30.11 (26.34)
28.15 (6.25) / 34.38 (9.41)
34.1 (12.6) 14
1993
RCT
High
38.61 (8.84) / 38.77 (8.54)
33
24.5 (27.52) / 22.83 (23.78)
38.61 (8.84) / 40.23 (8.21)
30
24.5 (27.52) / 18.28 (22.71)
38.61 (8.84) / 43.47 (7.64)
N/A
N/A
N/A
N/A
46
** / 3.0 (2.0)
** / 40.9 (5.8)
25
31.92 (26.63) / 28.92 (22.46)
27.17 (8.13) / 35.22 (9.19)
23
31.92 (26.63) / 17.85 (16.70)
27.17 (8.13) / 37.43 (9.37)
N/A
N/A
N/A
N/A
N/A
54
56
5.66 (2.47) / 4.76 (2.25)
29.89 (4.82) / 31.83 (5.41)
6.26 (2.35) / 4.67 (2.84)
31.20 (7.03) / 31.83 (7.17)
34.8 (17-61)
3
54
6.26 (2.35) / 3.15 (2.52)
31.20 (7.03) / 35.13 (6.72)
56
5.66 (2.47) / 5.08 (2.42)
29.89 (4.82) / 33.20 (7.61)
6
54
6.26 (2.35) / 1.51 (1.82)
31.20 (7.03) / 37.89 (6.53)
56
5.66 (2.47) / 4.39 (2.31)
29.89 (4.82) / 35.54 (6.41)
1
8
56 (21) / 23 (25)
27.6 (4.2) / 32.5 (4.2)
11
34 (17) / 18 (23)
31.4 (3.8) / 36.3 (5.6)
N/A
N/A
34 (17) / 9 (14)
31.4 (3.8) / 39.5 (5.5)
3 6
N/A 9
56 (21) / 11 (15)
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* : in cm for Vos et al., Sahlströme et al., Stegenga et al. // in mm for Schiffman et al., Diraçoğlu et al. **: unknown combined medical management and rehabilitation baseline values *** : Mean age for medical management // mean age for rehabilitation N/A: not available
24.5 (27.52) / 22.51 (24.35)
28.15 (6.25) / 31.54 (7.85)
33.4 (15-63)
overall 23.7 (6.7)
32
39.5 (29.58) / 33.56 (29.69)
N/A
27.6 (4.2) / 34.2 (3.6)
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Stegenga et al.
High
Baseline/post treatment MMO (SD
35.6 (15.6)
1 QuasiRCT
N/A
21
3
2009
N/A
6
6
Diraçoğlu et al.
Baseline/post treatment VAS (SD)*
33.7 (1.8) // 30 (1.7)***
31.8 (1.7) 3
2013
# of patients
36.1 (14.3)
1 Schiffman et al.
Mean age (SD or range)
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Design
Control
# of patients
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Year
Mean age (SD or range)
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Studies
Risk of bias
overall 23.7 (6.7)
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Table 2 : Pain reduction Follow-up (months)
Number of studies
Number of participants
1
2
155
3
2
147
6
2
178
1
2
85
3
1
65
6
2
78
Corticosteroïds
6
1
None
6
4
Subgroups
Standardized mean difference (95% CI)
I2 (%)
Intra-articular medication
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N/A : not applicable
0%
-0.42 [-0.76, -0.08]
92%
-0.76 [-1.09, -0.44]
95%
-0.34 [-0.78, 0.09]
43%
-0.57 [-1.07, -0.08]
N/A
-0.37 [-0.83, 0.08]
45%
68
0.14 [-0.37, 0.65]
N/A
188
-0.91 [-1.22, -0.61]
83%
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All other diagnosis
-0.01 [-0.33, 0.30]
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TMJ Closed lock
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Preoperative diagnosis
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Table 3 : Maximum mouth opening Follow-up (months)
Number of studies
Number of participants
1
2
155
3
2
147
6
2
177
1
2
85
3
1
65
6
2
78
Corticosteroïds
6
1
None
6
4
Subgroups
Standardized mean difference (95% CI)
I2 (%)
Intra-articular medication
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N/A : not applicable
0%
0.48 [-1.94, 2.90]
84%
1.72 [-0.33, 3.78]
0%
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All other diagnosis
-0.13 [-2.32, 2.05]
-2.92 [-5.73, - 0.10]
0%
-0.42 [-4.0, 3.16]
N/A
-3.28 [-5.88, -0.69]
46%
67
0.10 [-3.79, 3.99]
N/A
188
-0.27 [-2.04, 1.50]
83%
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TMJ Closed lock
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Preoperative diagnosis
Records identified through database searching (n = 4047)
Additional records identified through other sources (n = 0 )
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Records screened (n = 3492)
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Full-text articles assessed for eligibility (n = 10)
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Included
Eligibility
Screening
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Records after duplicates removed (n = 3492)
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Identification
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Studies included in qualitative synthesis (n = 5 )
Studies included in quantitative synthesis (meta-analysis) (n = 5)
Fig. 1: Flowchart of the study selection
Records excluded (n = 3482 )
Full-text articles excluded, with reasons (n = 5) Same study published twice : 2 Nonrandomized trials: 3
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S0278-2391(16)31315-5
DOI:
10.1016/j.joms.2016.12.027
Reference:
YJOMS 57589
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 23 October 2016 Revised Date:
28 November 2016
Accepted Date: 12 December 2016
Please cite this article as: Bouchard C, Goulet J-P, El-Ouazzani M, Fournier-Turgeon A, Temporomandibular lavage versus non-surgical treatments for temporomandibular disorders: A systematic review and meta-analysis, Journal of Oral and Maxillofacial Surgery (2017), doi: 10.1016/ j.joms.2016.12.027. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Temporomandibular lavage versus non-surgical treatments for temporomandibular disorders: A systematic review and metaanalysis
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Carl Bouchard, DMD, MSc, FRCD(C)1, 4; Jean-Paul Goulet, DDS, MSD2; Mehdi El-Ouazzani, DMD1, Alexis Fournier-Turgeon, MD, MSc (Epid.), FRCPC3 1
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Centre Hospitalier Universitaire (CHU) de Québec Université Laval Hôpital de l'Enfant-Jésus 1401, 18e rue Québec (Québec), Canada G1J 1Z4 Tel: 418-265-8744 Fax: 418-624-3338
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Associate professor, department of Oral and maxillofacial surgery - CHU de Québec – Université Laval (Hôpital de l’Enfant-Jésus), Québec (Québec), Canada 2 Resident, school of dental medicine, Université Laval, Québec (Québec), Canada 3 Associate professor, Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, and Université Laval Research Center, Population Health and Optimal Health Practices Unit (Trauma - Emergency - Critical Care Medicine), Québec (Québec), Canada 4 Corresponding author
[email protected]
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Conflict of interests: none Funding: none
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Key words: temporomandibular joint; arthroscopy; arthrocentesis, temporomandibular disorders; pain; mouth opening; lavage
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Abstract Purpose: To investigate the efficacy of temporomandibular joint (TMJ) lavage (arthrocentesis or arthroscopy) for
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the treatment of temporomandibular disorders (TMDs) in reducing pain and improve jaw motion.
Patients and methods: We performed a systematic review of the literature and meta-analysis of randomized-
controlled trials (RCT) comparing TMJ lavage to conservative measures. Data sources were MEDLINE, EMBASE, CENTRAL (Cochrane), Scopus and Web of Science and reference lists of relevant articles. Two independent
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reviewers identified RCTs by using controlled vocabulary (MeSH, Emtree) and free text terms. Data extracted from the selected studies were: population characteristics, intervention, outcomes and funding sources. Risk of bias was
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assessed using the Cochrane collaboration risk assessment tool for RCTs.
Results: Five studies met inclusion criteria, for a total of 308 patients. Three studies were categorized as having a high risk of bias and 2 had a low risk. The summary effect of the five studies showed a reduction in pain in the intervention group at 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001, I2 = 88%) and 3 months (-0.47, 95% CI [0.75, -0.19], p = 0.001, I2 = 85%). This was not the case at 1 month. No difference in mouth opening was observed
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at 6 months (-0.21, 95% CI [-1.82, 1.40], p < 0.80, I2 = 74%), 3 months (0.20, 95% CI [-1.81, 2.20], p = 0.85, I2 = 68%) and 1 month (-1.18, 95% CI [-2.90, 0.55], p = 0.18, I2 = 0%).
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Conclusion: Giving the relatively small number of patients included in this meta-analysis, the high risk of bias in 3 studies and the statistical and clinical heterogeneity of the included studies, the use of TMJ lavage for the treatment
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of TMDs should be recommended with cautions giving the lack of strong evidence to support its use.
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Introduction
Temporomandibular disorders (TMDs) are a heterogeneous group of musculoskeletal conditions affecting temporomandibular joints (TMJ), masticatory muscles and surrounding facial structures that can result in pain and
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limitation of jaw function.1 Not surprisingly, the etiology of TMDs can be quite varied and known causes include developmental, trauma, infection, autoimmune and neoplasms. However, the etiology of the most frequently seen muscle and joint disorders in clinic is at best speculative and factors that are frequently held as responsible for pain and dysfunction comprise bruxism, clenching, stress, malocclusion and estrogen imbalance in female patients. The
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often solicited during daily activities such as chewing and speaking.
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symptoms experienced by patients with a joint disorder can have a negative effect on their quality of life as TMJs are
Nonsteroidal anti-inflammatory drugs, muscle relaxants, splint therapy and physical therapy are usually used as the first line of treatment. Surgical interventions are contemplated when conservative and reversible treatments fail to relieve the patients’ symptoms and severe disability persists.2 TMJ lavage is a non-invasive procedure involving the irrigation of the upper joint space with isotonic saline solution.3, 4 It can be performed simply with two needles and
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an irrigation circuit (arthrocentesis) or with the use of an arthroscope (arthroscopy). The later technique was described by Ohnishi in 1975 and allows visualization of the structures of the upper joint space, but the potential therapeutic effect of both procedures have been demonstrated to be similar; therefore, they were considered as one
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intervention for the purpose of this research.5-7
In 2013, Vos et al. performed a systematic review (SR) of lavage therapy versus non-surgical treatment for arthralgia of the TMJ and concluded that lavage may be more effective, but only 3 randomized controlled studies were
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retained.8 Two of the studies had a high risk of bias and only a total of 85 patients received the intervention (TMJ lavage). Guo et al. did a SR on TMJ lavage in 2009, but they included studies with surgical procedures as the comparators.7 Because it appears that the current literature does not provide a clear answer on the potential efficacy of TMJ lavage, and no new randomized controlled trials (RCT) were published since the last SR by Vos et al. (2013), we decided to conduct a new SR of RCTs. The objective of the present SR is to evaluate the efficacy of TMJ lavage compared to non-surgical intervention by systematically searching the literature for studies assessing TMJ pain and function.
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Methods/design :
This SR was conducted in conformity with the Cochrane Collaboration principles for Systematic Reviews.9 The
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results obtained are reported according to PRISMA guidelines. The full peer-reviewed search strategy and research protocol defining eligibility criteria, selection process and data extraction were completed during the planning phase.
Databases, search terms and strategies:
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MEDLINE, EMBASE, CENTRAL (Cochrane), Scopus and Web of Science were searched up to May 1st, 2016 using controlled vocabulary (MeSH, Emtree) and free text terms. In addition the search included the International Clinical
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Trials Registry Platform (ICTRP) to identify ongoing studies. The search strategy was developed for MEDLINE (OVID) and modified accordingly to the database reviewed (see Appendix 1). The reference list of all included trials and previous narrative and systematic reviews were searched. There were no restrictions regarding the date of publication. Reference management used EndNote (Version X7, Thomas Reuters).
Studies were included if:
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Inclusion/exclusion criteria
1- they were randomized-controlled trials for the treatment of TMJ pain
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2- the intervention was TMJ lavage with needles (athrocentesis) alone or with the use of an arthroscope 3- the comparator was nonsurgical treatment
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4- the primary outcome was the reduction of pain 5- the secondary outcomes was one or more of the following: jaw function based on mouth opening, improvement in chewing abilities; improvement of quality of life; adverse effect of the procedure.
Studies were excluded if: 1- they were conducted on animals
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Study selection:
After the database search two authors (CB, MEO) read all the titles and abstracts to identify potentially eligible articles meeting the inclusion criteria. Articles without an abstract but with a title suggesting they could meet the
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inclusion criteria were kept to the next step. The full text of selected studies was retrieved and reviewed by 2 authors (CB, MEO). All studies fulfilling the inclusion criteria were retained for data extraction.
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Data extraction:
An Excel table for data extraction was built a priori to the review process. This table was tested on 2 selected
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studies to ensure that all relevant data could be extracted. The data extracted from the selected studies were the following:
Study characteristics: title, authors, journal/source, years and language of publication, country, type of study, study period, total number of patients, inclusion/exclusion criteria, randomization, allocation concealment, founding
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sources.
Sample characteristics: Age, sex, TMD diagnosis, follow-up duration and comorbidities. Interventions: Arthroscopy or arthrocentesis, type of medication infiltrated, analgesics. Comparator: type of intervention in the control group (placebo, no intervention, physiotherapy, etc.)
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Risk of bias
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Outcomes: all outcomes reported, including adverse events.
The risk of bias was assessed using the Cochrane collaboration risk assessment tool for RCTs.9 For each study, the following items were assessed for “low”, “high” or “unclear” risk of bias: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other biases.
Statistical analysis
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Review Manager (RevMan, version 5.3, the Nordic Cochrane Center, the Cochrane Collaboration) was used to analyze the data. Pain assessment (on a visual analog scale at rest or during movement) and mouth opening were reported as continuous variables with standard deviation (SD); therefore, the pooled effect of the intervention is
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reported as difference in means with 95% confidence interval (CI). A standardized mean difference was utilized for pain as the measurement scale varied across studies. Difference between groups was calculated using final value scores, not change-from-baseline scores, because the later data were not available for most studies. Evaluation of heterogeneity was calculated with I2 statistics. This test estimates the percentage of variation between study results
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that is due to heterogeneity rather than sampling error. Fixed effects model was favored because of the limited number of studies eligible (<5) and to avoid overpowering the results of smaller studies. We performed subgroup
potential sources of heterogeneity.
Results
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analyses for initial diagnosis and type of intra-articular medication injected at the time of TMJ lavage to find out
Our search strategy yielded a total of 3492 citations after removal of duplicates. After initial screening of the title and
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abstract ten articles were fully retrieved in full text and reviewed for eligibility. Of these 5 articles met the inclusion criteria (Figure. 1). Three studies were excluded because there was no randomization. The other two were studies reporting on the same cohort of patients with the same results published twice in 2 different journals. Schiffman et
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al. first reported in 2007 a RCT on the efficacy of four treatment strategies for TMD.10 The same study was also published in 2014, but using different outcome measures.1 The risk of bias was assessed with the later study because
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the method section was more explicit, but the results were extracted from the 2007 publication because specific values for pain intensity and maximal mouth opening are reported. A summary of the included studies is presented in table 1.
Individual study characteristics
Vos et al. compared arthrocentesis to conservative management (stepwise approach using soft diet, physical therapy,
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splint therapy) in a parallel group RCT.11 Patients with TMJ pain not responding to 2 weeks of non-steroidal antiinflammatory treatment were subjected to local anesthesia of the affected TMJ and randomized to either arthocentesis or usual conservative care if the anesthesia completely relieved their joint pain. Forty patients were
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randomized in each group after sample size calculation. Mean age of the patients in the intervention group (29 females) was 38.3 years (SD 15.9) and 36.1 years (SD 14.3) in the control group (31 females). Maximum active mouth opening (MMO) and pain at rest and during maximum mouth opening were the primary outcomes and were measured at baseline, 3 (T1), 12 (T2) and 26 (T3) weeks. Pain was assessed on a 0-100 mm visual analog scale
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(VAS). The examiner proceeding to the data collection was ignorant of the treatment allocation, but patient were not blinded to the intervention. Four patients dropped out in each group. Patients not showing at follow-up T1, T2 and
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T3 were respectively in the intervention and control group 2/4, 4/3 and 9/6. Because the results are presented with figures, the authors were contacted and they provided numerical data for VAS and MMO.
Schiffman et al. first published a RCT comparing 4 treatment strategies for TMJ closed lock in 2007.10 With the same data set the authors reassessed the effectiveness of the four treatment using outcome measures recommended by the International Association of Oral and Maxillofacial Surgeons in a paper published in 2014.1 A stratified
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randomization process was employed by dividing patients in two strata, depending if they had chronic disorder (> 6 months of limited mouth opening) or not (< 6 months). Unequal blocks of randomization were created because they anticipated that more patients would prefer medical management to other treatments. All patients had a magnetic
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resonance diagnosis of Wilkes’s stage III or IV closed lock. Twenty-nine patients (26 females, mean age 33.7 years, SD 1.8) were randomized in the medical management group (patient education, optimistic counseling, self-help
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program, systemic corticosteroids for 6 days followed by NSAIDS for up to 6 weeks), 25 patients (25 females, mean age 30 years, SD 1.7) received rehabilitation (medical management as described plus stabilization splints, physical therapy and cognitive behavioral therapy), 26 patients (22 females, mean age 31.8 years, SD 1.7) underwent arthroscopic surgery that included intracapsular injection of betamethasone and 26 patients (25 females, mean age 31.4 years, SD 1.9) had an arthroplasty (disc repositioning procedures when feasible or disc removal). An intention to treat analysis was employed so patients receiving additional therapy were evaluated according to their original treatment. Ten patients withdrew after randomization. Eight patients missed the 6-month follow-up (1 in the medical management group, 3 in rehabilitation group, 2 in the arthroscopic surgery group and 2 in the arthroplasty group).
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The primary outcome was the craniomandibular index and the modified symptom severity index and they were measured by an examiner blinded to the treatment at 3, 6, 12, 18, 24 and 60 months. Results of pain intensity and MMO were not published in this study, but were reported in a previous systematic review after the authors were
at 1 and 3 months, but no additional results were provided.
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contacted.8 These results were utilized in our meta-analysis. We also contacted the authors to obtain MMO and VAS
Sahlström et al. recruited 45 patients to participate in a single-blind RCT evaluating the short-term efficacy of local
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anesthesia and arthrocentesis compared to a control intervention limited to local anesthesia alone for the treatment of TMJ arthralgia of at least three months duration coupled with a diagnosis of disc displacement without reduction.12
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Both the control and intervention group received a premedication with 1000 mg paracetamol per os and received local anesthesia in the area of the TMJ (auriculotemporalis block) in preparation of a lavage treatment. The control group was then subjected to a simulated lavage procedure (saline was injected in a cup hidden from the patient after the installation of the drape) while the treatment group received a full lavage procedure with 50 ml of saline. Both groups were prescribed paracetamol 1000 mg for 3 days as needed. Randomization was performed using a table of random sampling numbers. An examiner not involved in the treatment of participants was responsible for this
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process. Similarly, patients were evaluated for pain and MMO at baseline, 1 and 3 months by a blinded examiner. Pain intensity was measured at rest and during movement with a 0-100 mm VAS. Maximum unassisted mouth opening without pain, maximum unassisted mouth opening and assisted maximum mouth opening were measured.
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Twenty patients (18 females, mean age 34.1 years, SD 12.6) underwent lavage and 25 (23 females, mean age 35.6 years, SD 15.6) had local anesthesia with simulated lavage. The number of patients was determined after sample
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size calculation. Eight patients withdrawn (6 in the intervention group) of the study because they received rescue treatment. Data up to that point were utilized to perform an intention-to-treat analysis.
Diraçoğlu et al. treated 120 patients (104 female) with non-reducing disk with either arthrocentesis or non-surgical treatment (stabilization splint day and night for 6 months except during eating and tooth brushing, heat packs daily for 10 days, home exercise programs for jaw muscle and range of motion).13 Patients with symptoms duration for a maximum of 3 weeks were allocated to one of the treatment groups alternatively as they were admitted to their multidisciplinary TMJ unit. Outcomes measured by a blinded examiner were pain measured on a 0-10 cm VAS and
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MMO at baseline, 1, 3 and 6 months. Ten patients were lost to follow up, leaving 54 individuals (51 females, mean age 33.4, ranges 15-63) in the intervention group and 56 (49 females, mean age 34.8, ranges 17-61) in the non-
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surgical group.
Stegenga et al. performed a RCT comparing arthroscopic surgery to physical therapy or no treatment for patients with TMJ pain and jaw movement limitation.14 A total of 28 patients were randomized to either one of the treatment groups. After 2 weeks of conservative treatment (exercises, soft diet, explanation), 7 patients were excluded because
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they were asymptomatic, leaving 21 patients (mean age 23.7, DS 6.7, ranges 17-41) to participate in the study (9 arthroscopic surgery, 12 conservative treatment). All patients in the arthroscopic surgery group had lavage of the
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joint space and either lysis of adhesion, disk mobilization, lateral release, coagulation of tissues or a combination of these. They also underwent physical therapy postoperatively. Pain intensity measured on a 0-100 mm VAS and MMO were evaluated at 1 and 6 months.
Risk of bias across studies
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A summary of the risk of bias analysis is presented in figure 2. Two studies were at low risk of bias (Schiffman et al., Vos et al.) and 3 were at high risk (Stegenga et al., Sahlström et al., Diraçoğlu et al.). Stegenga et al. did not report the method of randomization and Diraçoğlu et al. used an alternation method to assign patients in each group.
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Blinding of participants was not possible in most studies because the intervention was a surgical procedure. Examiners were not blinded in Diraçoğlu et al. and Stegenga et al. studies and this was considered a high risk of bias,
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giving the primary outcome was measurement of pain. A high risk attrition bias was observed in Sahlström et al. study due to the loss of 6/20 patients in their intervention group, compared to 2/25 in the control group. However, even if there were 3 times more dropouts between the first and third-month follow-up in the intervention group, it is doubtful that the conclusion of the study would have changed since all subjects dropping out underwent rescue treatment because of no improvement.
Results of individual studies
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Vos et al. observed a comparable decrease for pain at rest and with MMO, and improvement in MMO in both groups at 26 weeks (no p-values reported).11 Generalized estimated equations multivariate models demonstrated a significant difference between arthrocentesis and conservative treatments, showing that patients in the first group improved
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more rapidly (β coefficient for pain at rest: -11.42, 95% confidence interval -16.34, -6.50, p = 0.000; β coefficients for MMO: -2.70, confidence interval -5.35, -0.06, p = 0.045). Overtime, both treatments showed similar results.
Schiffman et al. reported in the 2007 study no significant improvement in pain (e.g. usual level of pain in the past
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month) (p = 0.14) and MMO (p = 0.52) after arthroscopy compared to non-surgical treatment (medical management and rehabilitation) at 6 months.10 No significant difference between groups at 3 (p = 0.23) and 6 months (0.083) was
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noted on the symptom severity index and self-measured pain index. Similarly, no differences between treatment groups were seen with the new outcomes reported in 2014 by the same authors as the original report.1
Sahlström et al. found a 30% pain reduction in 56% of the patients who received local anesthesia alone compared to 40% in the lavage group at 1 month (p = 0.286).12 At 3 months, corresponding numbers were respectively 76 and 55% (p = 0.138). Pain at rest and during jaw motion at 1 and 3 months did not differ significantly between groups (p
received.
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= 0.986 and p = 0.124 respectively). No significant difference was found for MMO, independent of the treatment
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Diraçoğlu et al. observed a significant improvement in pain (unspecified if pain at rest or with jaw motion or at MMO) with arthrocentesis compared to non-surgical treatment at 3 months (p = 0.01) and 6 months (p = 0.01). 13
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This was not the case at one month. MMO did not differ significantly at any time point between groups.
Stegenga et al. did showed a statistically significant difference in pain (TMJ pain at rest) between treatment groups based on subjective assessment evaluation at 1 and 6 months (p < 0.01).14 The same could not be demonstrated for jaw movement. Baseline pain intensity was significantly higher in the arthroscopic group compared to the control group (p < 0.05).
Synthesis of results
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Pain Pooled standardized mean difference for the reduction of pain between intervention and control showed a significant advantage for lavage at 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001, I2 = 88%) (Figure 3). This was also the
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case at 3 months (-0.47, 95% CI [-0.75, -0.19], p = 0.001, I2 = 85%), but not at 1 month (-0.13, 95% CI [-0.38, 0.13], p = 0.36, I2 = 9%)(Figures 4 and 5). Subgroup analysis showed that patients with TMJ closed lock had less pain at 6 months after lavage (-0.76 [-1.09, -0.44], p = 0.0000, I2 = 95%). The difference was not significant at any other time
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points. The injection of corticosteroids had no significant effect on pain (Table 2).
Mouth opening
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Pooled standardized mean difference for maximum mouth opening showed no difference between groups at 6 months (-0.21, 95% CI [-1.82, 1.40], p < 0.80, I2 = 74%), 3 months (0.20, 95% CI [-1.81, 2.20], p = 0.85, I2 = 68%) and 1 month (-1.18, 95% CI [-2.90, 0.55], p = 0.18, I2 = 0%) (Figures 6, 7 and 8). The subgroup analysis showed a significant reduction in mouth opening in the control group at 1 (-2.92 [-5.73, - 0.10], p = 0.04, I2 = 0%) and 6
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months (-3.28 [-5.88, -0.69], p = 0.01, I2 = 46%) when the diagnosis was not specifically a closed lock (Table 3).
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Discussion
This systematic review of TMJ lavage versus conservative measures identified 5 studies that met inclusion criteria.
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All were randomized10-12, 14 or quasi-randomized13 controlled trials. The only quasi-randomized trial had the largest sample of patients.13 TMJ lavage was superior to the control for the reduction of pain at 3 (-0.47, 95% CI [-0.75, 0.19], p = 0.001) and 6 months (-0.63, 95% CI [-0.90, -0.37], p < 0.00001). We did not show the superiority of the intervention for improvement in mouth opening at any time point (1 month: p = 0.18; 3 months: p = 0.85; 6 months:
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p > 0.80).
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These results have to be interpreted with caution, as there was a high risk of bias in 3 of the studies, including the one with the largest sample.12-14 There was no blinding of the examiner in one of the studies.12 This was considered a high risk of bias, as the primary outcome measured was pain. The overall sample size was relatively small (intervention: 135, control: 173) and one study only had 21 patients.14 Many patients across the studies were lost to follow up at different time points and only 2 studies adhered to an intention-to-treat protocol.10, 11 Substantial statistical heterogeneity at the 3 and 6 months analysis (I2 > 60%) was observed for both outcomes. There is also
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clinical heterogeneity between studies, as patients in the intervention and control group received different treatment modalities. Also, some patients had more acute diseases13 and other more chronic conditions with long-term pain and degenerative changes10, 12, 14. We performed a subgroup analysis comparing patients with closed lock (3 citations)10, to patients with an unspecified diagnosis (2 citations)11, 14 and found that lavage was more efficacious in
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reducing pain at 6 months. However, there were certainly patients with closed lock in the two studies with
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unspecified diagnosis.
Vos et al. reported similar results in a meta-analysis published in 2013.8 At 6 months, they observed a reduction in mean standardized differences for pain (- 1.07 [-1.38, -0.76), but not for MMO (-0.05 [-0.33, 0.23]). The 3 studies utilized for their SR were also retained in this research. They did not report pool effect at 1 and 3 months. A Cochrane collaboration review published by Guo et al. in 2009, included only 2 studies and concluded that there was insufficient data to either support or refute the use of TMJ lavage for the treatment of TMDs.7 It was recently withdrawn because it did not meet their current methodological standards.15 Murakami et al. enrolled 108 patients to
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participate in a prospective non-randomized clinical trial with 3 treatment arms: arthroscopy, arthrocentesis and non surgical.16 Patients improved significantly within each group, but the difference between treatments was not significant for pain and jaw motion. Kurita et al., compared arthroscopy to nonsurgical treatment in a prospective
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case-control study with the primary outcome being changes of the articular components of the TMJ (disc displacement, position, morphology, mobility, and degenerative change of the condyle) on magnetic resonance imaging.17 They also reported on patients’ satisfaction with treatment outcomes and observed that there were
significantly more patients (3/9 patients, p < 0.05) in the arthroscopic group with residual symptoms than in the
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control group. However, because patients were not randomized, it is likely that the ones who underwent surgical treatment had more severe conditions preoperatively. Goudot et al. reported a large prospective study involving 708
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patients with a variety of TMDs.6 All received 6 months of conservative measures. Patients still symptomatic after this period (n = 62, 8.8%) were assigned either to arthroscopy (33) or arthrocentesis (29). Of the 62 patients, 11 (18%) had no effect, 11 noted improvement and 40 (64%) had a complete elimination of pain. They also noted that arthroscopy was more effective than arthrocentesis to improve jaw motion. This was explained by the fact that arthroscopies were performed under general anesthesia, allowing more stretching and manipulations.
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There is no consensus on the benefits to inject intra-articular medications (corticosteroids, opioids, hyaluronic acid, etc.) at the end of a lavage procedure. We performed a subgroup analysis to evaluate the efficacy of intra-articular corticosteroids injection and it showed no effect on pain and mouth opening. This is similar to what Olgen-Bergem
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and Bjomland observed in a cohort study on patients with juvenile idiopathic arthritis.18 Thirty joints were treated either with arthrocentesis alone (n = 17) or with the injection triamcinolone hexacetonide (n = 21). Pain and
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function was evaluated at 3 and 8 months and was improved at both time points but there were no differences between treatment groups.
This systematic review with meta-analysis has the largest sample of patients ever reported. With the data available, we were able to perform analysis based on different postoperative follow up time (1, 3 and 6 months). This was never published in a meta-analysis before. Also, we followed a strict research protocol for study selection and risk of bias assessment. All major databases were reviewed, making it unlikely that eligible study were not identified. Limitations of this report include the clinical and statistical heterogeneity of the results and the high risk of bias for
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most of the studies retained. The preoperative diagnosis also varied among studies.
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Conclusion Although we demonstrated a beneficial effect of TMJ lavage on the reduction of pain at 3 and 6 months, the pooled effect on the reduction of pain remains minimal and may not by clinically significant. Before suggesting this
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procedure to patients, clinicians need to take into consideration that nonsurgical treatment may offer similar results, without the risk of complications. It appears that more RCTs comparing TMJ lavage compared to no intervention or placebo need to be implemented.
Legend
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Figure 1: Flow chart of the study selection
Figure 2: Summary of the risk of bias for each study (+ : low risk; - : high risk; ? : unclear risk)
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Figure 3: Forrest plot for the reduction of pain between lavage and conservative methods at 6 months Figure 4: Forrest plot for the reduction of pain between lavage and conservative methods at 3 months Figure 5: Forrest plot for the reduction of pain between lavage and conservative methods at 1 month Figure 6: Forrest plot for the increase in mouth opening between lavage and conservative methods at 6 months Figure 7: Forrest plot for the increase in mouth opening between lavage and conservative methods at 3 months
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Figure 8: Forrest plot for the increase in mouth opening between lavage and conservative methods at 1 month
Table 1: Characteristics of individual trials
Table 2: Subgroup analysis on the reduction of pain
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Table 3: Subgroup analysis on improvement in maximum mouth opening
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References
7. 8.
9.
10. 11. 12.
13.
14.
15. 16.
17.
18.
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Schiffman EL, Velly AM, Look JO et al.: Effects of four treatment strategies for temporomandibular joint closed lock. Int J Oral Maxillofac Surg 2014;43:217 Wilkes CH: Surgical treatment of internal derangements of the temporomandibular joint. A long-term study. Arch Otolaryngol Head Neck Surg 1991;117:64 Nitzan DW, Dolwick MF, Heft MW: Arthroscopic lavage and lysis of the temporomandibular joint: A change in perspective. Journal of Oral and Maxillofacial Surgery 1990;48:798 Al-Belasy FA, Dolwick MF: Arthrocentesis for the treatment of temporomandibular joint closed lock: a review article. International Journal of Oral and Maxillofacial Surgery 2007;36:773 Ohnishi M, Mizutani Y, Ishibashi K et al.: [Diagnostic application of arthroscope to ankylosis of the temporomandibular joint: report of two cases (author's transl)]. Nippon Koku Geka Gakkai Zasshi 1976;22:436 Goudot P, Jaquinet AR, Hugonnet S et al.: Improvement of pain and function after arthroscopy and arthrocentesis of the temporomandibular joint: A comparative study. Journal of Cranio-Maxillofacial Surgery 2000;28:39 Guo C, Shi Z, Revington P: Arthrocentesis and lavage for treating temporomandibular joint disorders. Cochrane Database Syst Rev 2009, CD004973 Vos LM, Huddleston Slater JJ, Stegenga B: Lavage therapy versus nonsurgical therapy for the treatment of arthralgia of the temporomandibular joint: a systematic review of randomized controlled trials. J Orofac Pain 2013;27:171 Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from http://www.cochranehandbook.org. Schiffman EL, Look JO, Hodges JS et al.: Randomized effectiveness study of four therapeutic strategies for TMJ closed lock. Journal of Dental Research 2007;86:58 Vos LM, Huddleston Slater JJ, Stegenga B: Arthrocentesis as initial treatment for temporomandibular joint arthropathy: a randomized controlled trial. J Craniomaxillofac Surg 2014;42:e134 Sahlstrom LE, Ekberg EC, List T et al.: Lavage treatment of painful jaw movements at disc displacement without reduction. A randomized controlled trial in a short-term perspective. International Journal of Oral & Maxillofacial Surgery 2013;42:356 Diracoglu D, Saral IB, Keklik B et al.: Arthrocentesis versus nonsurgical methods in the treatment of temporomandibular disc displacement without reduction. Oral Surgery Oral Medicine Oral Pathology Oral Radiology & Endodontics 2009;108:3 Stegenga B, de Bont LG, Dijkstra PU, Boering G: Short-term outcome of arthroscopic surgery of temporomandibular joint osteoarthrosis and internal derangement: a randomized controlled clinical trial. British Journal of Oral & Maxillofacial Surgery 1993;31:3 Guo C, Shi Z, Revington P: WITHDRAWN: Arthrocentesis and lavage for treating temporomandibular joint disorders. Cochrane Database Syst Rev 2015, CD004973 Murakami K, Hosaka H, Moriya Y et al.: Short-term treatment outcome study for the management of temporomandibular joint closed lock. A comparison of arthrocentesis to nonsurgical therapy and arthroscopic lysis and lavage. Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics 1995;80:253 Kurita H, Chen Z, Uehara S et al.: Comparison of Imaging Follow-Up Between Joints With Arthroscopic Surgery (Lysis and Lavage) and Those With Nonsurgical Treatment. Journal of Oral and Maxillofacial Surgery 2007;65:1309 Olsen-Bergem H, Bjornland T: A cohort study of patients with juvenile idiopathic arthritis and arthritis of the temporomandibular joint: outcome of arthrocentesis with and without the use of steroids. Int J Oral Maxillofac Surg 2014;43:990
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Intervention
2014
RCT
Low
38.3 (15.9)
Vos et al.
Month
Baseline/post treatment VAS (SD)*
Baseline/post treatment MMO (SD)
1
34
19.27 (21.51) / 11.79 (17.55)
34.66 (8.24) / 36.46 (6.4)
Sahlström et al.
2007
RCT
Low
3
32
19.27 (21.51) / 10.72 (17.36)
34.66 (8.24) / 39.81 (6.4)
6
27
19.27 (21.51) / 6.70 (16.96)
34.66 (8.24) / 41.78 (5.66)
N/A
N/A
RCT
High
6.8 (2.1) / 3.3 (2.2)
33.4 (7.6) / 41.0 (8.2)
1
20
39.5 (29.58) / 30.11 (26.34)
28.15 (6.25) / 34.38 (9.41)
34.1 (12.6) 14
1993
RCT
High
38.61 (8.84) / 38.77 (8.54)
33
24.5 (27.52) / 22.83 (23.78)
38.61 (8.84) / 40.23 (8.21)
30
24.5 (27.52) / 18.28 (22.71)
38.61 (8.84) / 43.47 (7.64)
N/A
N/A
N/A
N/A
46
** / 3.0 (2.0)
** / 40.9 (5.8)
25
31.92 (26.63) / 28.92 (22.46)
27.17 (8.13) / 35.22 (9.19)
23
31.92 (26.63) / 17.85 (16.70)
27.17 (8.13) / 37.43 (9.37)
N/A
N/A
N/A
N/A
N/A
54
56
5.66 (2.47) / 4.76 (2.25)
29.89 (4.82) / 31.83 (5.41)
6.26 (2.35) / 4.67 (2.84)
31.20 (7.03) / 31.83 (7.17)
34.8 (17-61)
3
54
6.26 (2.35) / 3.15 (2.52)
31.20 (7.03) / 35.13 (6.72)
56
5.66 (2.47) / 5.08 (2.42)
29.89 (4.82) / 33.20 (7.61)
6
54
6.26 (2.35) / 1.51 (1.82)
31.20 (7.03) / 37.89 (6.53)
56
5.66 (2.47) / 4.39 (2.31)
29.89 (4.82) / 35.54 (6.41)
1
8
56 (21) / 23 (25)
27.6 (4.2) / 32.5 (4.2)
11
34 (17) / 18 (23)
31.4 (3.8) / 36.3 (5.6)
N/A
N/A
34 (17) / 9 (14)
31.4 (3.8) / 39.5 (5.5)
3 6
N/A 9
56 (21) / 11 (15)
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* : in cm for Vos et al., Sahlströme et al., Stegenga et al. // in mm for Schiffman et al., Diraçoğlu et al. **: unknown combined medical management and rehabilitation baseline values *** : Mean age for medical management // mean age for rehabilitation N/A: not available
24.5 (27.52) / 22.51 (24.35)
28.15 (6.25) / 31.54 (7.85)
33.4 (15-63)
overall 23.7 (6.7)
32
39.5 (29.58) / 33.56 (29.69)
N/A
27.6 (4.2) / 34.2 (3.6)
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High
Baseline/post treatment MMO (SD
35.6 (15.6)
1 QuasiRCT
N/A
21
3
2009
N/A
6
6
Diraçoğlu et al.
Baseline/post treatment VAS (SD)*
33.7 (1.8) // 30 (1.7)***
31.8 (1.7) 3
2013
# of patients
36.1 (14.3)
1 Schiffman et al.
Mean age (SD or range)
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overall 23.7 (6.7)
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Table 2 : Pain reduction Follow-up (months)
Number of studies
Number of participants
1
2
155
3
2
147
6
2
178
1
2
85
3
1
65
6
2
78
Corticosteroïds
6
1
None
6
4
Subgroups
Standardized mean difference (95% CI)
I2 (%)
Intra-articular medication
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N/A : not applicable
0%
-0.42 [-0.76, -0.08]
92%
-0.76 [-1.09, -0.44]
95%
-0.34 [-0.78, 0.09]
43%
-0.57 [-1.07, -0.08]
N/A
-0.37 [-0.83, 0.08]
45%
68
0.14 [-0.37, 0.65]
N/A
188
-0.91 [-1.22, -0.61]
83%
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-0.01 [-0.33, 0.30]
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Table 3 : Maximum mouth opening Follow-up (months)
Number of studies
Number of participants
1
2
155
3
2
147
6
2
177
1
2
85
3
1
65
6
2
78
Corticosteroïds
6
1
None
6
4
Subgroups
Standardized mean difference (95% CI)
I2 (%)
Intra-articular medication
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N/A : not applicable
0%
0.48 [-1.94, 2.90]
84%
1.72 [-0.33, 3.78]
0%
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All other diagnosis
-0.13 [-2.32, 2.05]
-2.92 [-5.73, - 0.10]
0%
-0.42 [-4.0, 3.16]
N/A
-3.28 [-5.88, -0.69]
46%
67
0.10 [-3.79, 3.99]
N/A
188
-0.27 [-2.04, 1.50]
83%
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TMJ Closed lock
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Preoperative diagnosis
Records identified through database searching (n = 4047)
Additional records identified through other sources (n = 0 )
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Records screened (n = 3492)
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Full-text articles assessed for eligibility (n = 10)
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Included
Eligibility
Screening
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Records after duplicates removed (n = 3492)
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Identification
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Studies included in qualitative synthesis (n = 5 )
Studies included in quantitative synthesis (meta-analysis) (n = 5)
Fig. 1: Flowchart of the study selection
Records excluded (n = 3482 )
Full-text articles excluded, with reasons (n = 5) Same study published twice : 2 Nonrandomized trials: 3
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