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Does selective carious tissue removal of soft dentin increase the restorative failure risk in primary teeth?
Original Contributions
Systematic Review Does selective carious tissue removal of soft dentin increase the restorative failure risk in primary teeth? Systematic review and meta-analysis Djessica Pedrotti, DDS; Cleber Paradzinski Cavalheiro, DDS; Luciano Casagrande, MSc, PhD; Fernando Borba de Araújo, MSc, PhD; José Carlos Pettorossi Imparato, MSc, PhD; Rachel de Oliveira Rocha, MSc, PhD; Tathiane Larissa Lenzi, MSc, PhD ABSTRACT Background. The authors conducted a systematic review of randomized controlled trials comparing the risk of experiencing restoration failure in primary teeth after complete and selective carious tissue removal of soft dentin. Methods. The authors searched electronic databases (PubMed [MEDLINE], Scopus, Cochrane Central Register of Controlled Trials) and the ClinicalTrials.gov Web site with manual searching and cross-referencing for trials reporting restoration failure after follow-up of 6 months or longer. Two reviewers independently selected studies, extracted data, and assessed the risk of bias and quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. The authors performed intention-to-treat and per-protocol meta-analyses and calculated odds ratios (OR) as effect estimates in the random-effects model. Results. From 327 potentially eligible studies, the authors selected 23 for full-text screening and included 4. Results showed increased risk of experiencing restoration failure (intention-to-treat analysis, OR [95% confidence interval] 1.74 [1.01 to 3.00], and per-protocol analysis, OR [95% confidence interval] 1.79 [1.04 to 3.09]) after selective carious tissue removal of soft dentin. The risk of bias was high, and the quality of evidence was low. Conclusions. Selective carious tissue removal of soft dentin may increase the risk of experiencing restoration failure in primary teeth. However, the evidence level is insufficient for definitive conclusions. Practical Implications. Patients with restorations performed after selective carious tissue removal of soft dentin should have shorter recall visit intervals to evaluate the restorations’ quality and control caries disease, allowing for more conservative approaches, such as repair, in cases of defective restorations. Key Words. Partial excavation; one-step incomplete caries removal; deciduous tooth; survival restoration. JADA 2019:150(7):582-590 https://doi.org/10.1016/j.adaj.2019.02.018
T Copyright ª 2019 American Dental Association. All rights reserved.
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he principles of minimally invasive dentistry allow dentists to pursue holistic and cause-based management of caries disease to maintain healthy functional primary teeth until exfoliation.1,2 Restorative treatments are performed to aid biofilm control, protect the pulp-dentin complex, and restore the integrity of the dental structure, thereby recovering functional and esthetic needs and causing no unnecessary damage.1 Carious tissue removal ensures the conditions for a long-lasting restoration, preserves remineralizable tissue, maintains pulp vitality, and achieves an adequate seal. In deep lesions, selective carious tissue removal of soft dentin has been recommended to avoid pulp exposure and allow the placement of a durable restoration.1 Complete carious tissue removal in acute deep carious lesions has been proven to increase the occurrence of pulpal exposure and postoperative pulpal symptoms
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compared with selective carious tissue removal.3-5 Consequently, more complex interventions such as pulpotomy or pulpectomy are needed, increasing the clinical chair time6 and treatment costs.7 Furthermore, pulpotomized primary teeth tend to exfoliate earlier than those that undergo selective carious tissue removal.8 Despite the benefits of selective carious tissue removal in the maintenance of pulp vitality, evidence regarding restoration survival is limited.3 Although cavity sealing allows for the remineralization of carious dentin,9 rehardening of dentin is likely to occur gradually, particularly for deep lesions. Thus, demineralized dentin can act as a soft layer below the restoration and, under masticatory function, can fatigue and reduce the adhesion between the restoration and the dental structure.10,11 Because doubts remain regarding the restoration survival of teeth that undergo selective carious tissue removal of soft dentin,12,13 we conducted this systematic review to summarize and evaluate critically the results of randomized controlled trials comparing the risk of experiencing failure of restorations placed in primary teeth after complete and selective carious tissue removal of soft dentin. METHODS We conducted this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.14 Focused population, intervention, comparison, outcomes question We formulated the following research question to address the literature and outline the search strategy: Does selective carious tissue removal of soft dentin increase the risk of experiencing restoration failure in primary teeth compared with complete carious tissue removal? Data sources We performed a comprehensive literature search using the PubMed (MEDLINE), Scopus, and Cochrane Central Register of Controlled Trials databases to identify studies related to the research question and published through December 8, 2018. We conducted the search with no publication year or language limits. For the subject search, we used a combination of controlled vocabulary and text words based on the search strategy for the PubMed (MEDLINE) database. The search parameters are provided in the supplemental Appendix (available online at the end of this article). We adapted a sensitive search strategy for the Scopus and Cochrane Central Register of Controlled Trials databases. To reduce publication bias, we checked the ClinicalTrials.gov Web site for unpublished documents. We cross-checked the results of searching the various databases to locate and eliminate duplicates. The inclusion criterion was randomized clinical studies that compared complete carious tissue removal with selective carious tissue removal of soft dentin in primary teeth with deep cavitated lesions. In the selective carious tissue removal technique, soft carious tissue is left over the pulp, and the peripheral enamel and dentin are prepared to hard dentin.1 The exclusion criteria were follow-up was less than 6 months, dropout rate was higher than 30%, there was absence of similar follow-up for patients in both groups evaluated in the same way, did not consider hardness of dentin as primary criterion for performing carious removal techniques, did not perform conventional restorative treatment, did not evaluate restoration failure as outcome, and did not use clinical criteria for evaluating the restorations. At minimum, the following parameters should have been considered in the evaluation of the outcome: marginal integrity and partial or total loss of the restoration. If needed, we contacted the authors via e-mail to answer questions about the carious tissue removal technique. Search steps: screening and selection Step 1 Two authors (C.P.C., D.P.) independently reviewed titles and abstracts and selected articles for further review if they met the inclusion criterion. The calculation of interexaminer agreement (k ¼ 0.92) indicated excellent agreement. Step 2 Two authors (C.P.C., D.P.) retrieved and independently reviewed the full text of articles selected in the previous step. They evaluated the reference lists of the articles selected in this step and the full texts of the articles potentially relating to the research question. JADA 150(7)
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ABBREVIATION KEY CR: Complete carious tissue removal. NA: Not applicable. PP: Per-protocol. SR: Selective carious tissue removal. USPHS: US Public Health Service.
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Identification Screening Eligibility Included
Records identified through database searching PubMed (MEDLINE) (n = 43), Scopus (n = 34), Cochrane Central Register of Clinical Trials (n = 239), ClinicalTrials.gov (n = 14)
Records after duplicates removed (n = 327)
Records screened (n = 327)
Records excluded (n = 304)*
Full-text articles assessed for eligibility (n = 23)
Full-text articles excluded, with reasons (n = 19)†
Studies included in qualitative and quantitative syntheses (n = 4)
Figure 1. Flow diagram of the study selection according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.14 * Exclusions: did not compare selective versus complete carious tissue removal (n ¼ 219), was not clinical trial (n ¼ 89), did not use primary teeth (n ¼ 52). † Exclusions: dropout rate was higher than 30% (n ¼ 1), had follow-up of less than 6 months (n ¼ 6), did not evaluate restoration survival as outcome (n ¼ 11), did not use criteria for evaluation restoration quality (n ¼ 3), did not perform conventional restorative treatment (n ¼ 1).
In both steps, any disagreement was firstly resolved via discussion between the reviewers (C.P.C., D.P.). If discrepancies remained, they consulted a third author (T.L.L.). Data extraction Both reviewers independently collected the eligible studies’ data. For each study, they systematically extracted publication details (authors, year, and country), sample characteristics (number and age of participants, sample size, caries risk profile), methodology (commercial brand and manufacturer of the restorative materials, use or nonuse of cavity lining, criteria to assess carious tissue removal, method of operative field, number of operators), and outcome information (follow-up and dropout, restorative failures, clinical criteria for evaluating restorations, any secondary outcomes such as pulp exposure). Assessment of risk of bias and quality of evidence of the included studies Two reviewers (C.P.C., D.P.) independently assessed the risk of bias, according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1.15 They divided the criteria into 7 domains: selection bias (sequence generation, allocation concealment), performance and detection bias (blinding of participants, operators, outcome assessment), attrition bias (incomplete outcome data), and reporting bias (selective outcome reporting). They evaluated the studies by means of rating each domain as having low, high, or unclear risk of bias (no information or uncertainty over the potential for bias). For the final classification of risk of bias, the reviewers resolved disagreements via consensus. The reviewers assessed the quality of evidence for the outcome effect estimate according to the guidelines of the Grading of Recommendations, Assessment, Development, and Evaluations work group.16 Data analyses We performed conventional meta-analyses using random-effects models in Review Manager Software Version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration). We calculated odds ratios 584
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(ORs) and 95% confidence intervals (CIs). Values lower than 1.0 indicate that selective carious tissue removal technique has lower risk of experiencing restoration failure than complete carious tissue removal technique and vice versa for values greater than 1.0. We performed intention-to-treat (ITT) analysis (analysis of participants as randomized regardless of whether they received the intervention or were available for follow-up) and perprotocol (PP) analysis (analysis of participants based on the intervention they received and their availability for follow-up) to account for possible bias introduced by attrition and protocol deviations. For our ITT analysis, we assumed that all missing participants experienced an event. We assessed heterogeneity using both Cochran Q and I2 statistics. Owing to the low number of trials, we performed no further subgroup or meta-regression analysis. In 1 study,17 researchers performed selective carious tissue removal of soft dentin followed by restoration with glass ionomer cement or by lining with black copper cement and restoration. We excluded teeth restored with black copper cement for analyses, because black copper cement is not a usual cavity lining for incomplete caries removal, and there is no solid evidence for its recommendation. RESULTS Study selection The search strategy identified 327 potentially relevant studies, excluding duplicates. After the screening of titles and abstracts, we assessed 23 studies for more detailed information. We excluded 19 studies after a review of the full-text articles. Finally, 4 randomized controlled trials met the eligibility criteria and were included in the systematic review. Figure 1 presents a flowchart of the study selection process and the reasons for exclusions. Characteristics of the included studies The 4 studies were conducted in Brazil,18,19 Scotland,17 and Thailand.20 All studies were published in English, and the trials were reported from 1999 through 2015. The follow-up period ranged from 1218,20 through 24 months,17,19 with dropout rates of 0% through 28.3%. All studies included occlusal and occlusoproximal cavities, and a range of materials (liners and restorative materials) had been used. In 2 studies, researchers performed the restorations with rubber dam isolation.18,19 A more detailed summary of the included studies is presented in Table 1. Meta-analysis We observed a significant difference in the risk of experiencing failure between complete and selective carious tissue removal of soft dentin approaches (Figure 2), with a lower risk of experiencing failure for restorations placed after complete carious tissue removal (ITT analysis, OR [95% CI] 1.74 [1.01 to 3.00]; per-protocol analysis, OR [95% CI] 1.79 [1.04 to 3.09]). The heterogeneity was low, regardless of the analysis performed (4% in the ITT analysis and 0% in the PP analysis). Assessment of risk of bias and quality of evidence of the included studies The final assessment of the risk of bias in the included studies is summarized in Table 2. A statement regarding the randomization method was reported in all evaluated studies; however, the authors in 1 study did not describe the method used to generate the random sequence,18 leading to an unclear risk of bias. Moreover, most studies had an unclear risk of bias regarding the allocation concealment.18-20 All studies were classified as having a high risk of bias regarding the blinding of operators, because blinding is not possible when performing dental restorations. Two studies had an unclear risk of bias regarding the blinding of the examiner.17,18 Thus, the risk of bias was considered high. A low quality of evidence was judged according to the guidelines of the Grading of Recommendations, Assessment, Development, and Evaluations work group (Table 3).16 DISCUSSION It has been well established that the selective carious tissue removal technique for managing deep cavitated lesions reduces the risk of experiencing pulp exposure and postoperative pulpal symptoms,3,4 potentially avoiding complicated treatments. Previous systematic reviews4,5 with JADA 150(7)
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Table 1. Main characteristics of data sets from randomized selected studies for systematic review.
STUDY DESIGN
PARTICIPANTS, NO. (AGE, Y)
SELECTIVE CARIOUS TISSUE REMOVAL (CRITERIA AND TECHNIQUE)
TYPE OF CARIES
STUDY
COUNTRY
MATERIAL
CAVITY LINER
Ribeiro and Colleagues,18 1999
Brazil
Parallel group
38 (7-11)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft and moist dentin) Removal with low-speed drills
Composite resin (Filtek Z100, 3M ESPE)
NA‡
Foley and Colleagues,17 2004
Scotland
Split-mouth
44 (3-9)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with low-speed drills
Glass ionomer cement (Chemfil Superior, Dentsply)
NA
Phonghanyudh Thailand and Colleagues,20 2012
Parallel group
182 (6-11)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with spoon excavator
Glass ionomer cement (Fuji IX, GC)
NA
Franzon and Colleagues,19 2015
Parallel group
48 (3-8)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with low-speed drills
Composite resin (Filtek Z350, 3M ESPE)
Calcium hydroxide cement (Dycal, Dentsply)
Brazil
* PP: Per-protocol. † ITT: Intention-to-treat. ‡ NA: Not applicable. § USPHS: US Public Health Service. { CR: Complete carious tissue removal. # SR: Selective carious tissue removal.
Study or Subgroup
Selective Caries Removal Events Total
Ribeiro and Colleagues,18 1999 Foley and Colleagues,17 2004 Phonghanyudh and Colleagues,20 2012 Franzon and Colleagues,19 2015
0 10 15 22
20 30 89 66
Total (95% CI) 205 Total events 47 Heterogeneity: τ2 = 0.00; χ22 = 1.86 (P = .40); I2 = 0% Test for overall effect: Z = 2.11 (P = .03)
Study or Subgroup
Selective Caries Removal Events Total
Ribeiro and Colleagues,18 1999 Foley and Colleagues,17 2004 Phonghanyudh and Colleagues,20 2012 Franzon and Colleagues,19 2015
0 10 15 22
24 43 92 66
Total (95% CI) 225 Total events 47 Heterogeneity: τ2 = 0.01; χ22 = 2.08 (P = .35); I2 = 4% Test for overall effect: Z = 1.99 (P = .05)
Complete Caries Odds Ratio Removal Mantel-Haenszel Method, Events Total Weight Random, 95% CI 0 9 10 8
20 29 88 54
24.6% 39.7% 35.7%
Not estimable 1.11 (0.37 to 3.32) 1.58 (0.67 to 3.74) 2.88 (1.16 to 7.13)
191 100.0%
1.79 (1.04 to 3.09)
Odds Ratio Mantel-Haenszel Method, Random, 95% CI
27 0.01
0.1 Selective Caries Removal
Complete Caries Odds Ratio Removal Mantel-Haenszel Method, Events Total Weight Random, 95% CI 0 9 10 8
24 41 90 54
27.3% 38.3% 34.4%
Not estimable 1.08 (0.39 to 3.00) 1.56 (0.66 to 3.68) 2.88 (1.16 to 7.13)
209 100.0%
1.74 (1.01 to 3.00)
1
10 Complete Caries Removal
100
Odds Ratio Mantel-Haenszel Method, Random, 95% CI
27 0.01
0.1 Selective Caries Removal
1
10 Complete Caries Removal
100
Figure 2. Meta-analyses for failure of restorations after selective and complete carious tissue removal using per-protocol and intention-to-treat analyses, subsequently. Study data, weighted odds ratios and 95% confidence intervals (95% CI), heterogeneity I2, and overall effect statistics, as well as forest plots are shown.
limited quality of evidence have shown similar risks of failure for both complete and incomplete excavation in primary and permanent teeth. The systematic review authors defined failure as technical or biological complications demanding intervention (for example, restorations lost or requiring replacement, pulpitis, and nonrestorable teeth).4,5 To the best of our knowledge, ours is the first systematic review and meta-analysis to update the scientific literature with an answer to the question of whether selective carious tissue removal of soft dentin jeopardizes the 586
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Table 1. (Continued)
OPERATOR, (NO.)
CRITERIA
FAILURE REASONS
FOLLOWUP (MO), DROPOUT RATE (%)
FIELD ISOLATION
PULPAL OUTCOME
RESTORATIVE OUTCOME (NO. OF RESTORATIONS/ FAILED RESTORATIONS) PP* Analysis ITT† Analysis
NA
Total retention, partial or total loss of restoration plus marginal integrity (USPHS§)
NA
12, 16
Rubber dam
Pulpal symptoms 1 (CR{)
24/0 (SR) 24/0 (CR)
30/10 (SR) 29/9 (CR)
43/10 (SR) 41/9 (CR)
4
Clinical and radiographic examination
Partial or total loss of restoration associated with adjacent caries
24, 28.3
Cotton pellets
NA
Frencken and colleagues2
Marginal defect, loss of restoration and wear of restoration deeper than 0.5 mm with adjacent caries
12, 2.7
Cotton pellets
Pulpal exposure 2 (CR) Pulpal symptoms 2 (CR)
89/15 (SR) 88/10 (SR)
92/15 (SR) 90/10 (CR)
USPHS
Anatomic form, marginal discoloration, marginal integrity, partial lost and adjacent caries
Rubber dam
Pulpal exposure 2 (SR) and 15 (CR)
66/22 (SR) 54/8 (CR)
66/22 (SR) 54/8 (CR)
3
24, 0
-
20/0 (SR#) 20/0 (CR)
Table 2. Methodological assessment of risk of bias of included studies. STUDY
METHODOLOGICAL QUALITY ITEM
Selection Bias Random sequence generation
Allocation concealment
Detection Bias Blinding of participants
Blinding of personnel
Blinding of outcome assessment
Attrition Bias
Reporting Bias
Incomplete outcome data
Selective reporting
Ribeiro and Colleagues,18 1999
Unclear
Unclear
Low
High
Unclear
Low
Low
Foley and Colleagues,17 2004
Low
Low
Unclear
High
Unclear
Low
Low
Phonghanyudh and Colleagues,20 2012
Low
Unclear
Low
High
Low
Low
Low
Franzon and Colleagues,19 2015
Low
Unclear
Low
High
Low
Low
Low
longevity of restorations placed in primary molars. We considered only restoration failure as an outcome. We performed both ITT and PP analyses. PP analyses served as a sensitivity analysis to ITT analyses for checking the robustness of findings and impact of attrition. Irrespective of the analysis, restorations placed after selective carious tissue removal of soft dentin had a higher risk of experiencing failure than those performed after complete carious tissue removal. The heterogeneity was low. In findings from a laboratory study, researchers reported that the fracture strength for restored teeth after incomplete excavation was lower than that for teeth that underwent complete excavation.12 The researchers observed the presence of “ice-cracks” in restorations placed after incomplete carious tissue removal, indicating that the restorations collapsed into the underlying soft layer of carious dentin.12 The adequate sealing of carious dentin promotes its remineralization,9 resulting in greater hardness and stiffness and, consequently, higher fracture strength over time. In deeper lesions, the rehardening of dentin may occur only gradually, increasing the risk of experiencing nonpulpal failures. A major problem for all studies investigating selective carious tissue removal (and most likely complete excavation as well) is measuring the degree of excavation (that is, the amount of carious tissue left or removed). The International Caries Consensus Collaboration recommends JADA 150(7)
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Table 3. A summary of the Grading of Recommendations Assessment, Development, and Evaluation* approach to rating quality of evidence. NO. OF RESTORATIONS
CERTAINTY ASSESSMENT
No. of Studies
Study Design
EFFECT
CERTAINTY IMPORTANCE
Selective Complete Relative (95% Carious Carious Risk of Other Tissue Tissue Confidence Bias Inconsistency Indirectness Imprecision Considerations Removal Removal Interval)
4
Randomized Serious† Not serious clinical trials
Not serious
Serious‡
None
205
191
Odds ratio Low 1.79 (1.04 to 3.09)
Important
4
Randomized Serious† Not serious clinical trials
Not serious
Serious‡
None
225
209
Odds ratio Low 1.74 (1.01 to 3.00)
Important
* Under the Grading of Recommendations, Assessment, Development, and Evaluation framework,16 there are 4 grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate of effect. † Problems with the form of randomization, allocation concealment, and blinding of operators were detected. ‡ Few studies and few restorations assessed.
selective removal of soft dentin in cases of deeper lesions.1 Hardness of dentin should be the main parameter for assessing, describing, and reporting carious tissue and its removal. 1 However, disagreements can still occur as to how much carious dentin should be removed, in part because of insufficient methods for easily, reproducibly, and objectively measuring caries removal. The thickness of the carious layer left behind may influence the long-term behavior of restorations. Additional studies are necessary to answer these questions. The outcome in the studies in our systematic review most likely was affected by several confounders that we could not evaluate owing to the paucity of data. The authors used different criteria for determining restoration failure. The authors adopted the Modified US Public Health Service criteria in 2 studies,19,20 used Frencken and colleagues’ evaluation criteria in 1 study,5 and performed clinical evaluation without use of validated criteria in the other study.17 However, in all of the included studies, the authors considered relevant parameters related to outcome such as marginal integrity and restoration loss (partial or total). The authors of 1 study also considered other parameters such as marginal discoloration and anatomic form,20 which may have overestimated the restorative failures because these aspects may not be directly related to carious tissue removal techniques. The material used (composite resin or glass ionomer cement) for cavity restoration, as well as the use or nonuse of lining material, also might have affected the outcome. Nevertheless, the same restorative material was used after both complete and selective carious tissue removal techniques. The material type (composite resin, glass ionomer cement, and calcium hydroxide) does affect the risk of experiencing failure of the indirect pulp treatment in primary molars.21 In addition, no definitive evidence supports 1 material as being more suitable than another for restoring teeth after selective carious tissue removal.1 Therefore, the choice of restorative material should be based on the extent of the carious lesions, caries risk, specific patient conditions, and setting.1 Occlusal and occlusoproximal restorations were performed in the included studies and were analyzed together. Nevertheless, a higher number of surfaces in cavity preparations can reduce the survival rate of restorations.19,22 Large proximal cavities result in preparations with boxes that have limited retention because of the shape of primary molars. A high restoration failure rate can occur with a higher number of surfaces, particularly when a soft layer of carious dentin remains inside the cavity.19 Moreover, removing all carious tissue from the cervical wall and subsequently promoting adequate sealing of margins in proximal cavities is more technically difficult. Clinicians must not be discouraged from performing incomplete excavation for treating deep carious lesions, because this approach may avoid more invasive interventions and, subsequently, reduce clinical chair time, patient discomfort, and treatment costs.23 In a microsimulation study comparing the cost-effectiveness of different excavations in low- and high-risk patients, the advantages of selective excavation were more pronounced in high-risk groups than those of stepwise and complete excavation.24 Functional retention of the tooth and its vitality are clinically relevant outcomes. Although pulpal outcomes were not included in our analysis, we observed that complete carious tissue removal resulted in more cases of pulpal exposure or pulpal symptoms (Table 1).
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One of the advantages of adhesive composite restorations is that they allow repairs. Even if the restorations present shortcomings over time, most could be repaired, allowing more conservative approaches for teeth with deep carious lesions. In addition to fracture, presence of adjacent caries is a common cause of restoration failure.25 Therefore, intervals for the patient recall visits should be shorter, and clinicians must place greater emphasis on controlling the etiologic factors of caries disease. Considering the shorter biological life span of primary teeth compared with permanent teeth and the psychological impact of invasive treatments on young children, a less invasive treatment option is preferable. The effect of the underlying quality of evidence on the findings must be emphasized. We assessed few studies and few restorations. The follow-up periods of the included studies were shorter than desired (12 or 24 months), which is a major shortcoming of the dataset. Differences in restoration failure rates between approaches could be greater with longer follow-up periods. However, primary teeth have lower longevity of restorations owing to exfoliation. Allocation concealment remained unclear in most of the studies. In addition, randomization and allocation always were performed before carious tissue excavation. Thus, the operator was aware of the allocation and consequently may have removed different amounts of carious tissue. Blinding of the examiner was also unclear in some studies. CONCLUSIONS Selective carious tissue removal of soft dentin may increase the risk of experiencing restoration failure in primary teeth. Owing to the limited evidence level, well-designed and reported randomized trials are required before definitive conclusions can be drawn. n SUPPLEMENTAL DATA Supplemental data related to this article can be found at: https://doi.org/10.1016/j.adaj.2019.02.018.
Dr. Pedrotti is an MSc student, Dental Science Graduate Program, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Cavalheiro is an MSc Student, Dental Science Graduate Program, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Casagrande is an associate professor, School of Dentistry, PostGraduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Dr. Araújo is a professor, School of Dentistry, Post-Graduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Dr. Imparato is an associate professor, Department of Orthodontics and Pediatric Dentistry, School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil.
1. Schwendicke F, Frencken JE, Bjørndal L, et al. Managing carious lesions: consensus recommendations on carious tissue removal. Adv Dent Res. 2016;28(2):58-67. 2. Frencken JE, Peters MC, Manton DJ, Leal SC, Gordan VV, Eden E. Minimal intervention dentistry for managing dental caries: a reviewdreport of a FDI task group. Int Dent J. 2012;62(5):223-243. 3. Ricketts D, Lamont T, Innes NPT, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013;3:CD003808. 4. Schwendicke F, Dörfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013;92(4):306-314. 5. Li T, Zhai X, Song F, Zhu H. Selective versus nonselective removal for dental caries: a systematic review and meta-analysis. Acta Odontol Scand. 2018;76(2):135-140. 6. Franzon R, Guimarães LF, Magalhães CE, Haas AN, Araujo FB. Outcomes of one-step
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Dr. Rocha is an associate professor, Department of Stomatology, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Lenzi is an assistant professor, School of Dentistry, Post-Graduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Ramiro Barcelos 2492, 90035-003, Santa Cecília, Porto Alegre, Rio Grande do Sul, Brazil, e-mail [email protected]. Address correspondence to Dr. Lenzi. Disclosure. None of the authors reported any disclosures. This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES), Finance Code 001.
incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-383. 7. Schwendicke F, Krois J, Splieth CH, et al. Costeffectiveness of managing cavitated primary molar caries lesions: a randomized trial in Germany. J Dent. 2018;78: 40-45. 8. Fuks AB. Vital pulp therapy with new materials for primary teeth: new directions and treatment perspectives. Pediatr Dent. 2008;30(3):211-219. 9. Dalpian DM, Casagrande L, Franzon R, Dutra GMC, de Araujo FB. Dentin microhardness of primary teeth undergoing partial carious removal. J Clin Pediatr Dent. 2012;36(4):363-367. 10. Alves FB, Lenzi TL, Reis A, Loguercio AD, Carvalho TS, Raggio DP. Bonding of simplified adhesive systems to caries-affected dentin of primary teeth. J Adhes Dent. 2013;15(5):439-445.
11. Yoshiyama M, Tay FR, Doi J, et al. Bonding of selfetch and total-etch adhesives to carious dentin. J Dent Res. 2002;81(8):556-560. 12. Hevinga MA, Opdam NJ, Frencken JE, Truin GJ, Huysmans MC. Does incomplete caries removal reduce strength of restored teeth? J Dent Res. 2010;89(11): 1270-1275. 13. Schwendicke F, Kern M, Meyer-Lueckel H, Boels A, Doerfer C, Paris S. Fracture resistance and cuspal deflection of incompletely excavated teeth. J Dent. 2014;42(2):107-113. 14. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;21(6):e1000097. 15. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.0.1. Available at www.cochrane-handbook.org. Accessed September 15, 2018..
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16. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3drating the quality of evidence. J Clin Epidemiol. 2011;64(4):401-406. 17. Foley J, Evans D, Blackwell A. Partial caries removal and cariostatic materials in carious primary molar teeth: a randomised controlled clinical trial. Br Dent J. 2004; 197(11):697-701. 18. Ribeiro CC, Baratieri LN, Perdigao J, Baratieri NM, Ritter AV. A clinical, radiographie, and scanning electron microscopic evaluation of adhesive restorations on carious dentin in primary teeth. Quintessence Int. 1999;30(9): 591-599. 19. Franzon R, Opdam NJ, Guimarães LF, et al. Randomized controlled clinical trial of the 24-months survival
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of composite resin restorations after one-step incomplete and complete excavation on primary teeth. J Dent. 2015; 43(10):1235-1241. 20. Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen PE. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Community Dent Health. 2012;29(2): 173-178. 21. Santos PS, Pedrotti D, Braga MM, Rocha R, de O, Lenzi TL. Materials used for indirect pulp treatment in primary teeth: a mixed treatment comparisons metaanalysis. Braz Oral Res. 2017;31(0):e101. 22. Pedrotti D, Ribeiro JF, Weber Pires C, et al. Survival and associated risk factors of resin-based
composite restorations in primary teeth: a clinical, retrospective, university-based study. Pediatr Dent. 2017;39(4):313-318. 23. Schwendicke F, Stolpe M, Meyer-Lueckel H, Paris S, Dörfer CE. Cost-effectiveness of one- and two-step incomplete and complete excavations. J Dent Res. 2013; 92(10):880-887. 24. Schwendicke F, Paris S, Stolpe M. Cost-effectiveness of caries excavations in different risk groups: a micro-simulation study. BMC Oral Health. 2014; 14(1):153. 25. Opdam NJM, van de Sande FH, Bronkhorst E, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93(10):943-949.
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Appendix - Search strategy for PubMed (MEDLINE) database. (((((((((((((((tooth, deciduous) OR tooth, deciduous[MeSH Terms]) OR deciduous tooth) OR deciduous teeth) OR primary tooth) OR primary teeth) OR primary dentition) OR deciduous dentition) OR milk tooth) OR milk teeth) OR baby tooth) OR baby teeth)) AND (((((((((((((((((minimally invasive dentistry) OR incomplete excavation) OR selective excavation) OR stepwise excavation) OR indirect pulp treatment) OR partially excavation) OR selective removal) OR selective caries removal) OR selective carious removal) OR partial removal) OR partial caries removal) OR partial carious removal)) OR selective removal to firm dentine) OR selective removal to soft dentine)) OR one-step incomplete removal)) AND ((((((((((((((((total removal) OR total caries removal) OR total carious removal) OR non-selective removal) OR nonselective caries removal) OR non-selective carious removal) OR non-selective decay removal)) OR complete excavation) OR complete caries excavation) OR complete carious excavation) OR complete removal) OR complete caries removal) OR complete carious removal)) AND ((((clinical [Title/Abstract] AND trial[Title/Abstract]) OR clinical trials as topic[MeSH Terms] OR clinical trial[Publication Type] OR random*[Title/Abstract] OR random allocation[MeSH Terms] OR therapeutic use[MeSH Subheading])))
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Systematic Review Does selective carious tissue removal of soft dentin increase the restorative failure risk in primary teeth? Systematic review and meta-analysis Djessica Pedrotti, DDS; Cleber Paradzinski Cavalheiro, DDS; Luciano Casagrande, MSc, PhD; Fernando Borba de Araújo, MSc, PhD; José Carlos Pettorossi Imparato, MSc, PhD; Rachel de Oliveira Rocha, MSc, PhD; Tathiane Larissa Lenzi, MSc, PhD ABSTRACT Background. The authors conducted a systematic review of randomized controlled trials comparing the risk of experiencing restoration failure in primary teeth after complete and selective carious tissue removal of soft dentin. Methods. The authors searched electronic databases (PubMed [MEDLINE], Scopus, Cochrane Central Register of Controlled Trials) and the ClinicalTrials.gov Web site with manual searching and cross-referencing for trials reporting restoration failure after follow-up of 6 months or longer. Two reviewers independently selected studies, extracted data, and assessed the risk of bias and quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. The authors performed intention-to-treat and per-protocol meta-analyses and calculated odds ratios (OR) as effect estimates in the random-effects model. Results. From 327 potentially eligible studies, the authors selected 23 for full-text screening and included 4. Results showed increased risk of experiencing restoration failure (intention-to-treat analysis, OR [95% confidence interval] 1.74 [1.01 to 3.00], and per-protocol analysis, OR [95% confidence interval] 1.79 [1.04 to 3.09]) after selective carious tissue removal of soft dentin. The risk of bias was high, and the quality of evidence was low. Conclusions. Selective carious tissue removal of soft dentin may increase the risk of experiencing restoration failure in primary teeth. However, the evidence level is insufficient for definitive conclusions. Practical Implications. Patients with restorations performed after selective carious tissue removal of soft dentin should have shorter recall visit intervals to evaluate the restorations’ quality and control caries disease, allowing for more conservative approaches, such as repair, in cases of defective restorations. Key Words. Partial excavation; one-step incomplete caries removal; deciduous tooth; survival restoration. JADA 2019:150(7):582-590 https://doi.org/10.1016/j.adaj.2019.02.018
T Copyright ª 2019 American Dental Association. All rights reserved.
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he principles of minimally invasive dentistry allow dentists to pursue holistic and cause-based management of caries disease to maintain healthy functional primary teeth until exfoliation.1,2 Restorative treatments are performed to aid biofilm control, protect the pulp-dentin complex, and restore the integrity of the dental structure, thereby recovering functional and esthetic needs and causing no unnecessary damage.1 Carious tissue removal ensures the conditions for a long-lasting restoration, preserves remineralizable tissue, maintains pulp vitality, and achieves an adequate seal. In deep lesions, selective carious tissue removal of soft dentin has been recommended to avoid pulp exposure and allow the placement of a durable restoration.1 Complete carious tissue removal in acute deep carious lesions has been proven to increase the occurrence of pulpal exposure and postoperative pulpal symptoms
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compared with selective carious tissue removal.3-5 Consequently, more complex interventions such as pulpotomy or pulpectomy are needed, increasing the clinical chair time6 and treatment costs.7 Furthermore, pulpotomized primary teeth tend to exfoliate earlier than those that undergo selective carious tissue removal.8 Despite the benefits of selective carious tissue removal in the maintenance of pulp vitality, evidence regarding restoration survival is limited.3 Although cavity sealing allows for the remineralization of carious dentin,9 rehardening of dentin is likely to occur gradually, particularly for deep lesions. Thus, demineralized dentin can act as a soft layer below the restoration and, under masticatory function, can fatigue and reduce the adhesion between the restoration and the dental structure.10,11 Because doubts remain regarding the restoration survival of teeth that undergo selective carious tissue removal of soft dentin,12,13 we conducted this systematic review to summarize and evaluate critically the results of randomized controlled trials comparing the risk of experiencing failure of restorations placed in primary teeth after complete and selective carious tissue removal of soft dentin. METHODS We conducted this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.14 Focused population, intervention, comparison, outcomes question We formulated the following research question to address the literature and outline the search strategy: Does selective carious tissue removal of soft dentin increase the risk of experiencing restoration failure in primary teeth compared with complete carious tissue removal? Data sources We performed a comprehensive literature search using the PubMed (MEDLINE), Scopus, and Cochrane Central Register of Controlled Trials databases to identify studies related to the research question and published through December 8, 2018. We conducted the search with no publication year or language limits. For the subject search, we used a combination of controlled vocabulary and text words based on the search strategy for the PubMed (MEDLINE) database. The search parameters are provided in the supplemental Appendix (available online at the end of this article). We adapted a sensitive search strategy for the Scopus and Cochrane Central Register of Controlled Trials databases. To reduce publication bias, we checked the ClinicalTrials.gov Web site for unpublished documents. We cross-checked the results of searching the various databases to locate and eliminate duplicates. The inclusion criterion was randomized clinical studies that compared complete carious tissue removal with selective carious tissue removal of soft dentin in primary teeth with deep cavitated lesions. In the selective carious tissue removal technique, soft carious tissue is left over the pulp, and the peripheral enamel and dentin are prepared to hard dentin.1 The exclusion criteria were follow-up was less than 6 months, dropout rate was higher than 30%, there was absence of similar follow-up for patients in both groups evaluated in the same way, did not consider hardness of dentin as primary criterion for performing carious removal techniques, did not perform conventional restorative treatment, did not evaluate restoration failure as outcome, and did not use clinical criteria for evaluating the restorations. At minimum, the following parameters should have been considered in the evaluation of the outcome: marginal integrity and partial or total loss of the restoration. If needed, we contacted the authors via e-mail to answer questions about the carious tissue removal technique. Search steps: screening and selection Step 1 Two authors (C.P.C., D.P.) independently reviewed titles and abstracts and selected articles for further review if they met the inclusion criterion. The calculation of interexaminer agreement (k ¼ 0.92) indicated excellent agreement. Step 2 Two authors (C.P.C., D.P.) retrieved and independently reviewed the full text of articles selected in the previous step. They evaluated the reference lists of the articles selected in this step and the full texts of the articles potentially relating to the research question. JADA 150(7)
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ABBREVIATION KEY CR: Complete carious tissue removal. NA: Not applicable. PP: Per-protocol. SR: Selective carious tissue removal. USPHS: US Public Health Service.
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Identification Screening Eligibility Included
Records identified through database searching PubMed (MEDLINE) (n = 43), Scopus (n = 34), Cochrane Central Register of Clinical Trials (n = 239), ClinicalTrials.gov (n = 14)
Records after duplicates removed (n = 327)
Records screened (n = 327)
Records excluded (n = 304)*
Full-text articles assessed for eligibility (n = 23)
Full-text articles excluded, with reasons (n = 19)†
Studies included in qualitative and quantitative syntheses (n = 4)
Figure 1. Flow diagram of the study selection according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.14 * Exclusions: did not compare selective versus complete carious tissue removal (n ¼ 219), was not clinical trial (n ¼ 89), did not use primary teeth (n ¼ 52). † Exclusions: dropout rate was higher than 30% (n ¼ 1), had follow-up of less than 6 months (n ¼ 6), did not evaluate restoration survival as outcome (n ¼ 11), did not use criteria for evaluation restoration quality (n ¼ 3), did not perform conventional restorative treatment (n ¼ 1).
In both steps, any disagreement was firstly resolved via discussion between the reviewers (C.P.C., D.P.). If discrepancies remained, they consulted a third author (T.L.L.). Data extraction Both reviewers independently collected the eligible studies’ data. For each study, they systematically extracted publication details (authors, year, and country), sample characteristics (number and age of participants, sample size, caries risk profile), methodology (commercial brand and manufacturer of the restorative materials, use or nonuse of cavity lining, criteria to assess carious tissue removal, method of operative field, number of operators), and outcome information (follow-up and dropout, restorative failures, clinical criteria for evaluating restorations, any secondary outcomes such as pulp exposure). Assessment of risk of bias and quality of evidence of the included studies Two reviewers (C.P.C., D.P.) independently assessed the risk of bias, according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1.15 They divided the criteria into 7 domains: selection bias (sequence generation, allocation concealment), performance and detection bias (blinding of participants, operators, outcome assessment), attrition bias (incomplete outcome data), and reporting bias (selective outcome reporting). They evaluated the studies by means of rating each domain as having low, high, or unclear risk of bias (no information or uncertainty over the potential for bias). For the final classification of risk of bias, the reviewers resolved disagreements via consensus. The reviewers assessed the quality of evidence for the outcome effect estimate according to the guidelines of the Grading of Recommendations, Assessment, Development, and Evaluations work group.16 Data analyses We performed conventional meta-analyses using random-effects models in Review Manager Software Version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration). We calculated odds ratios 584
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(ORs) and 95% confidence intervals (CIs). Values lower than 1.0 indicate that selective carious tissue removal technique has lower risk of experiencing restoration failure than complete carious tissue removal technique and vice versa for values greater than 1.0. We performed intention-to-treat (ITT) analysis (analysis of participants as randomized regardless of whether they received the intervention or were available for follow-up) and perprotocol (PP) analysis (analysis of participants based on the intervention they received and their availability for follow-up) to account for possible bias introduced by attrition and protocol deviations. For our ITT analysis, we assumed that all missing participants experienced an event. We assessed heterogeneity using both Cochran Q and I2 statistics. Owing to the low number of trials, we performed no further subgroup or meta-regression analysis. In 1 study,17 researchers performed selective carious tissue removal of soft dentin followed by restoration with glass ionomer cement or by lining with black copper cement and restoration. We excluded teeth restored with black copper cement for analyses, because black copper cement is not a usual cavity lining for incomplete caries removal, and there is no solid evidence for its recommendation. RESULTS Study selection The search strategy identified 327 potentially relevant studies, excluding duplicates. After the screening of titles and abstracts, we assessed 23 studies for more detailed information. We excluded 19 studies after a review of the full-text articles. Finally, 4 randomized controlled trials met the eligibility criteria and were included in the systematic review. Figure 1 presents a flowchart of the study selection process and the reasons for exclusions. Characteristics of the included studies The 4 studies were conducted in Brazil,18,19 Scotland,17 and Thailand.20 All studies were published in English, and the trials were reported from 1999 through 2015. The follow-up period ranged from 1218,20 through 24 months,17,19 with dropout rates of 0% through 28.3%. All studies included occlusal and occlusoproximal cavities, and a range of materials (liners and restorative materials) had been used. In 2 studies, researchers performed the restorations with rubber dam isolation.18,19 A more detailed summary of the included studies is presented in Table 1. Meta-analysis We observed a significant difference in the risk of experiencing failure between complete and selective carious tissue removal of soft dentin approaches (Figure 2), with a lower risk of experiencing failure for restorations placed after complete carious tissue removal (ITT analysis, OR [95% CI] 1.74 [1.01 to 3.00]; per-protocol analysis, OR [95% CI] 1.79 [1.04 to 3.09]). The heterogeneity was low, regardless of the analysis performed (4% in the ITT analysis and 0% in the PP analysis). Assessment of risk of bias and quality of evidence of the included studies The final assessment of the risk of bias in the included studies is summarized in Table 2. A statement regarding the randomization method was reported in all evaluated studies; however, the authors in 1 study did not describe the method used to generate the random sequence,18 leading to an unclear risk of bias. Moreover, most studies had an unclear risk of bias regarding the allocation concealment.18-20 All studies were classified as having a high risk of bias regarding the blinding of operators, because blinding is not possible when performing dental restorations. Two studies had an unclear risk of bias regarding the blinding of the examiner.17,18 Thus, the risk of bias was considered high. A low quality of evidence was judged according to the guidelines of the Grading of Recommendations, Assessment, Development, and Evaluations work group (Table 3).16 DISCUSSION It has been well established that the selective carious tissue removal technique for managing deep cavitated lesions reduces the risk of experiencing pulp exposure and postoperative pulpal symptoms,3,4 potentially avoiding complicated treatments. Previous systematic reviews4,5 with JADA 150(7)
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Table 1. Main characteristics of data sets from randomized selected studies for systematic review.
STUDY DESIGN
PARTICIPANTS, NO. (AGE, Y)
SELECTIVE CARIOUS TISSUE REMOVAL (CRITERIA AND TECHNIQUE)
TYPE OF CARIES
STUDY
COUNTRY
MATERIAL
CAVITY LINER
Ribeiro and Colleagues,18 1999
Brazil
Parallel group
38 (7-11)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft and moist dentin) Removal with low-speed drills
Composite resin (Filtek Z100, 3M ESPE)
NA‡
Foley and Colleagues,17 2004
Scotland
Split-mouth
44 (3-9)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with low-speed drills
Glass ionomer cement (Chemfil Superior, Dentsply)
NA
Phonghanyudh Thailand and Colleagues,20 2012
Parallel group
182 (6-11)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with spoon excavator
Glass ionomer cement (Fuji IX, GC)
NA
Franzon and Colleagues,19 2015
Parallel group
48 (3-8)
Occlusal and One-step occlusoproximal Visual and tactile criteria (soft dentin) Removal with low-speed drills
Composite resin (Filtek Z350, 3M ESPE)
Calcium hydroxide cement (Dycal, Dentsply)
Brazil
* PP: Per-protocol. † ITT: Intention-to-treat. ‡ NA: Not applicable. § USPHS: US Public Health Service. { CR: Complete carious tissue removal. # SR: Selective carious tissue removal.
Study or Subgroup
Selective Caries Removal Events Total
Ribeiro and Colleagues,18 1999 Foley and Colleagues,17 2004 Phonghanyudh and Colleagues,20 2012 Franzon and Colleagues,19 2015
0 10 15 22
20 30 89 66
Total (95% CI) 205 Total events 47 Heterogeneity: τ2 = 0.00; χ22 = 1.86 (P = .40); I2 = 0% Test for overall effect: Z = 2.11 (P = .03)
Study or Subgroup
Selective Caries Removal Events Total
Ribeiro and Colleagues,18 1999 Foley and Colleagues,17 2004 Phonghanyudh and Colleagues,20 2012 Franzon and Colleagues,19 2015
0 10 15 22
24 43 92 66
Total (95% CI) 225 Total events 47 Heterogeneity: τ2 = 0.01; χ22 = 2.08 (P = .35); I2 = 4% Test for overall effect: Z = 1.99 (P = .05)
Complete Caries Odds Ratio Removal Mantel-Haenszel Method, Events Total Weight Random, 95% CI 0 9 10 8
20 29 88 54
24.6% 39.7% 35.7%
Not estimable 1.11 (0.37 to 3.32) 1.58 (0.67 to 3.74) 2.88 (1.16 to 7.13)
191 100.0%
1.79 (1.04 to 3.09)
Odds Ratio Mantel-Haenszel Method, Random, 95% CI
27 0.01
0.1 Selective Caries Removal
Complete Caries Odds Ratio Removal Mantel-Haenszel Method, Events Total Weight Random, 95% CI 0 9 10 8
24 41 90 54
27.3% 38.3% 34.4%
Not estimable 1.08 (0.39 to 3.00) 1.56 (0.66 to 3.68) 2.88 (1.16 to 7.13)
209 100.0%
1.74 (1.01 to 3.00)
1
10 Complete Caries Removal
100
Odds Ratio Mantel-Haenszel Method, Random, 95% CI
27 0.01
0.1 Selective Caries Removal
1
10 Complete Caries Removal
100
Figure 2. Meta-analyses for failure of restorations after selective and complete carious tissue removal using per-protocol and intention-to-treat analyses, subsequently. Study data, weighted odds ratios and 95% confidence intervals (95% CI), heterogeneity I2, and overall effect statistics, as well as forest plots are shown.
limited quality of evidence have shown similar risks of failure for both complete and incomplete excavation in primary and permanent teeth. The systematic review authors defined failure as technical or biological complications demanding intervention (for example, restorations lost or requiring replacement, pulpitis, and nonrestorable teeth).4,5 To the best of our knowledge, ours is the first systematic review and meta-analysis to update the scientific literature with an answer to the question of whether selective carious tissue removal of soft dentin jeopardizes the 586
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Table 1. (Continued)
OPERATOR, (NO.)
CRITERIA
FAILURE REASONS
FOLLOWUP (MO), DROPOUT RATE (%)
FIELD ISOLATION
PULPAL OUTCOME
RESTORATIVE OUTCOME (NO. OF RESTORATIONS/ FAILED RESTORATIONS) PP* Analysis ITT† Analysis
NA
Total retention, partial or total loss of restoration plus marginal integrity (USPHS§)
NA
12, 16
Rubber dam
Pulpal symptoms 1 (CR{)
24/0 (SR) 24/0 (CR)
30/10 (SR) 29/9 (CR)
43/10 (SR) 41/9 (CR)
4
Clinical and radiographic examination
Partial or total loss of restoration associated with adjacent caries
24, 28.3
Cotton pellets
NA
Frencken and colleagues2
Marginal defect, loss of restoration and wear of restoration deeper than 0.5 mm with adjacent caries
12, 2.7
Cotton pellets
Pulpal exposure 2 (CR) Pulpal symptoms 2 (CR)
89/15 (SR) 88/10 (SR)
92/15 (SR) 90/10 (CR)
USPHS
Anatomic form, marginal discoloration, marginal integrity, partial lost and adjacent caries
Rubber dam
Pulpal exposure 2 (SR) and 15 (CR)
66/22 (SR) 54/8 (CR)
66/22 (SR) 54/8 (CR)
3
24, 0
-
20/0 (SR#) 20/0 (CR)
Table 2. Methodological assessment of risk of bias of included studies. STUDY
METHODOLOGICAL QUALITY ITEM
Selection Bias Random sequence generation
Allocation concealment
Detection Bias Blinding of participants
Blinding of personnel
Blinding of outcome assessment
Attrition Bias
Reporting Bias
Incomplete outcome data
Selective reporting
Ribeiro and Colleagues,18 1999
Unclear
Unclear
Low
High
Unclear
Low
Low
Foley and Colleagues,17 2004
Low
Low
Unclear
High
Unclear
Low
Low
Phonghanyudh and Colleagues,20 2012
Low
Unclear
Low
High
Low
Low
Low
Franzon and Colleagues,19 2015
Low
Unclear
Low
High
Low
Low
Low
longevity of restorations placed in primary molars. We considered only restoration failure as an outcome. We performed both ITT and PP analyses. PP analyses served as a sensitivity analysis to ITT analyses for checking the robustness of findings and impact of attrition. Irrespective of the analysis, restorations placed after selective carious tissue removal of soft dentin had a higher risk of experiencing failure than those performed after complete carious tissue removal. The heterogeneity was low. In findings from a laboratory study, researchers reported that the fracture strength for restored teeth after incomplete excavation was lower than that for teeth that underwent complete excavation.12 The researchers observed the presence of “ice-cracks” in restorations placed after incomplete carious tissue removal, indicating that the restorations collapsed into the underlying soft layer of carious dentin.12 The adequate sealing of carious dentin promotes its remineralization,9 resulting in greater hardness and stiffness and, consequently, higher fracture strength over time. In deeper lesions, the rehardening of dentin may occur only gradually, increasing the risk of experiencing nonpulpal failures. A major problem for all studies investigating selective carious tissue removal (and most likely complete excavation as well) is measuring the degree of excavation (that is, the amount of carious tissue left or removed). The International Caries Consensus Collaboration recommends JADA 150(7)
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Table 3. A summary of the Grading of Recommendations Assessment, Development, and Evaluation* approach to rating quality of evidence. NO. OF RESTORATIONS
CERTAINTY ASSESSMENT
No. of Studies
Study Design
EFFECT
CERTAINTY IMPORTANCE
Selective Complete Relative (95% Carious Carious Risk of Other Tissue Tissue Confidence Bias Inconsistency Indirectness Imprecision Considerations Removal Removal Interval)
4
Randomized Serious† Not serious clinical trials
Not serious
Serious‡
None
205
191
Odds ratio Low 1.79 (1.04 to 3.09)
Important
4
Randomized Serious† Not serious clinical trials
Not serious
Serious‡
None
225
209
Odds ratio Low 1.74 (1.01 to 3.00)
Important
* Under the Grading of Recommendations, Assessment, Development, and Evaluation framework,16 there are 4 grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate of effect. † Problems with the form of randomization, allocation concealment, and blinding of operators were detected. ‡ Few studies and few restorations assessed.
selective removal of soft dentin in cases of deeper lesions.1 Hardness of dentin should be the main parameter for assessing, describing, and reporting carious tissue and its removal. 1 However, disagreements can still occur as to how much carious dentin should be removed, in part because of insufficient methods for easily, reproducibly, and objectively measuring caries removal. The thickness of the carious layer left behind may influence the long-term behavior of restorations. Additional studies are necessary to answer these questions. The outcome in the studies in our systematic review most likely was affected by several confounders that we could not evaluate owing to the paucity of data. The authors used different criteria for determining restoration failure. The authors adopted the Modified US Public Health Service criteria in 2 studies,19,20 used Frencken and colleagues’ evaluation criteria in 1 study,5 and performed clinical evaluation without use of validated criteria in the other study.17 However, in all of the included studies, the authors considered relevant parameters related to outcome such as marginal integrity and restoration loss (partial or total). The authors of 1 study also considered other parameters such as marginal discoloration and anatomic form,20 which may have overestimated the restorative failures because these aspects may not be directly related to carious tissue removal techniques. The material used (composite resin or glass ionomer cement) for cavity restoration, as well as the use or nonuse of lining material, also might have affected the outcome. Nevertheless, the same restorative material was used after both complete and selective carious tissue removal techniques. The material type (composite resin, glass ionomer cement, and calcium hydroxide) does affect the risk of experiencing failure of the indirect pulp treatment in primary molars.21 In addition, no definitive evidence supports 1 material as being more suitable than another for restoring teeth after selective carious tissue removal.1 Therefore, the choice of restorative material should be based on the extent of the carious lesions, caries risk, specific patient conditions, and setting.1 Occlusal and occlusoproximal restorations were performed in the included studies and were analyzed together. Nevertheless, a higher number of surfaces in cavity preparations can reduce the survival rate of restorations.19,22 Large proximal cavities result in preparations with boxes that have limited retention because of the shape of primary molars. A high restoration failure rate can occur with a higher number of surfaces, particularly when a soft layer of carious dentin remains inside the cavity.19 Moreover, removing all carious tissue from the cervical wall and subsequently promoting adequate sealing of margins in proximal cavities is more technically difficult. Clinicians must not be discouraged from performing incomplete excavation for treating deep carious lesions, because this approach may avoid more invasive interventions and, subsequently, reduce clinical chair time, patient discomfort, and treatment costs.23 In a microsimulation study comparing the cost-effectiveness of different excavations in low- and high-risk patients, the advantages of selective excavation were more pronounced in high-risk groups than those of stepwise and complete excavation.24 Functional retention of the tooth and its vitality are clinically relevant outcomes. Although pulpal outcomes were not included in our analysis, we observed that complete carious tissue removal resulted in more cases of pulpal exposure or pulpal symptoms (Table 1).
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One of the advantages of adhesive composite restorations is that they allow repairs. Even if the restorations present shortcomings over time, most could be repaired, allowing more conservative approaches for teeth with deep carious lesions. In addition to fracture, presence of adjacent caries is a common cause of restoration failure.25 Therefore, intervals for the patient recall visits should be shorter, and clinicians must place greater emphasis on controlling the etiologic factors of caries disease. Considering the shorter biological life span of primary teeth compared with permanent teeth and the psychological impact of invasive treatments on young children, a less invasive treatment option is preferable. The effect of the underlying quality of evidence on the findings must be emphasized. We assessed few studies and few restorations. The follow-up periods of the included studies were shorter than desired (12 or 24 months), which is a major shortcoming of the dataset. Differences in restoration failure rates between approaches could be greater with longer follow-up periods. However, primary teeth have lower longevity of restorations owing to exfoliation. Allocation concealment remained unclear in most of the studies. In addition, randomization and allocation always were performed before carious tissue excavation. Thus, the operator was aware of the allocation and consequently may have removed different amounts of carious tissue. Blinding of the examiner was also unclear in some studies. CONCLUSIONS Selective carious tissue removal of soft dentin may increase the risk of experiencing restoration failure in primary teeth. Owing to the limited evidence level, well-designed and reported randomized trials are required before definitive conclusions can be drawn. n SUPPLEMENTAL DATA Supplemental data related to this article can be found at: https://doi.org/10.1016/j.adaj.2019.02.018.
Dr. Pedrotti is an MSc student, Dental Science Graduate Program, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Cavalheiro is an MSc Student, Dental Science Graduate Program, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Casagrande is an associate professor, School of Dentistry, PostGraduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Dr. Araújo is a professor, School of Dentistry, Post-Graduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Dr. Imparato is an associate professor, Department of Orthodontics and Pediatric Dentistry, School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil.
1. Schwendicke F, Frencken JE, Bjørndal L, et al. Managing carious lesions: consensus recommendations on carious tissue removal. Adv Dent Res. 2016;28(2):58-67. 2. Frencken JE, Peters MC, Manton DJ, Leal SC, Gordan VV, Eden E. Minimal intervention dentistry for managing dental caries: a reviewdreport of a FDI task group. Int Dent J. 2012;62(5):223-243. 3. Ricketts D, Lamont T, Innes NPT, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013;3:CD003808. 4. Schwendicke F, Dörfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013;92(4):306-314. 5. Li T, Zhai X, Song F, Zhu H. Selective versus nonselective removal for dental caries: a systematic review and meta-analysis. Acta Odontol Scand. 2018;76(2):135-140. 6. Franzon R, Guimarães LF, Magalhães CE, Haas AN, Araujo FB. Outcomes of one-step
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Dr. Rocha is an associate professor, Department of Stomatology, Federal University of Santa Maria, Santa Maria, Brazil. Dr. Lenzi is an assistant professor, School of Dentistry, Post-Graduate Program in Pediatric Dentistry, Federal University of Rio Grande do Sul, Ramiro Barcelos 2492, 90035-003, Santa Cecília, Porto Alegre, Rio Grande do Sul, Brazil, e-mail [email protected]. Address correspondence to Dr. Lenzi. Disclosure. None of the authors reported any disclosures. This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES), Finance Code 001.
incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-383. 7. Schwendicke F, Krois J, Splieth CH, et al. Costeffectiveness of managing cavitated primary molar caries lesions: a randomized trial in Germany. J Dent. 2018;78: 40-45. 8. Fuks AB. Vital pulp therapy with new materials for primary teeth: new directions and treatment perspectives. Pediatr Dent. 2008;30(3):211-219. 9. Dalpian DM, Casagrande L, Franzon R, Dutra GMC, de Araujo FB. Dentin microhardness of primary teeth undergoing partial carious removal. J Clin Pediatr Dent. 2012;36(4):363-367. 10. Alves FB, Lenzi TL, Reis A, Loguercio AD, Carvalho TS, Raggio DP. Bonding of simplified adhesive systems to caries-affected dentin of primary teeth. J Adhes Dent. 2013;15(5):439-445.
11. Yoshiyama M, Tay FR, Doi J, et al. Bonding of selfetch and total-etch adhesives to carious dentin. J Dent Res. 2002;81(8):556-560. 12. Hevinga MA, Opdam NJ, Frencken JE, Truin GJ, Huysmans MC. Does incomplete caries removal reduce strength of restored teeth? J Dent Res. 2010;89(11): 1270-1275. 13. Schwendicke F, Kern M, Meyer-Lueckel H, Boels A, Doerfer C, Paris S. Fracture resistance and cuspal deflection of incompletely excavated teeth. J Dent. 2014;42(2):107-113. 14. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;21(6):e1000097. 15. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.0.1. Available at www.cochrane-handbook.org. Accessed September 15, 2018..
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16. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3drating the quality of evidence. J Clin Epidemiol. 2011;64(4):401-406. 17. Foley J, Evans D, Blackwell A. Partial caries removal and cariostatic materials in carious primary molar teeth: a randomised controlled clinical trial. Br Dent J. 2004; 197(11):697-701. 18. Ribeiro CC, Baratieri LN, Perdigao J, Baratieri NM, Ritter AV. A clinical, radiographie, and scanning electron microscopic evaluation of adhesive restorations on carious dentin in primary teeth. Quintessence Int. 1999;30(9): 591-599. 19. Franzon R, Opdam NJ, Guimarães LF, et al. Randomized controlled clinical trial of the 24-months survival
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of composite resin restorations after one-step incomplete and complete excavation on primary teeth. J Dent. 2015; 43(10):1235-1241. 20. Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen PE. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Community Dent Health. 2012;29(2): 173-178. 21. Santos PS, Pedrotti D, Braga MM, Rocha R, de O, Lenzi TL. Materials used for indirect pulp treatment in primary teeth: a mixed treatment comparisons metaanalysis. Braz Oral Res. 2017;31(0):e101. 22. Pedrotti D, Ribeiro JF, Weber Pires C, et al. Survival and associated risk factors of resin-based
composite restorations in primary teeth: a clinical, retrospective, university-based study. Pediatr Dent. 2017;39(4):313-318. 23. Schwendicke F, Stolpe M, Meyer-Lueckel H, Paris S, Dörfer CE. Cost-effectiveness of one- and two-step incomplete and complete excavations. J Dent Res. 2013; 92(10):880-887. 24. Schwendicke F, Paris S, Stolpe M. Cost-effectiveness of caries excavations in different risk groups: a micro-simulation study. BMC Oral Health. 2014; 14(1):153. 25. Opdam NJM, van de Sande FH, Bronkhorst E, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93(10):943-949.
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Appendix - Search strategy for PubMed (MEDLINE) database. (((((((((((((((tooth, deciduous) OR tooth, deciduous[MeSH Terms]) OR deciduous tooth) OR deciduous teeth) OR primary tooth) OR primary teeth) OR primary dentition) OR deciduous dentition) OR milk tooth) OR milk teeth) OR baby tooth) OR baby teeth)) AND (((((((((((((((((minimally invasive dentistry) OR incomplete excavation) OR selective excavation) OR stepwise excavation) OR indirect pulp treatment) OR partially excavation) OR selective removal) OR selective caries removal) OR selective carious removal) OR partial removal) OR partial caries removal) OR partial carious removal)) OR selective removal to firm dentine) OR selective removal to soft dentine)) OR one-step incomplete removal)) AND ((((((((((((((((total removal) OR total caries removal) OR total carious removal) OR non-selective removal) OR nonselective caries removal) OR non-selective carious removal) OR non-selective decay removal)) OR complete excavation) OR complete caries excavation) OR complete carious excavation) OR complete removal) OR complete caries removal) OR complete carious removal)) AND ((((clinical [Title/Abstract] AND trial[Title/Abstract]) OR clinical trials as topic[MeSH Terms] OR clinical trial[Publication Type] OR random*[Title/Abstract] OR random allocation[MeSH Terms] OR therapeutic use[MeSH Subheading])))
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