- Email: [email protected]
Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs?
Journal Pre-proof Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs? Sercan Küçükkurt, DDS PhD, Mehmet Kağan Değerliyurt, DDS PhD PII:
S0278-2391(20)30106-3
DOI:
https://doi.org/10.1016/j.joms.2020.01.030
Reference:
YJOMS 59066
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 22 April 2019 Revised Date:
22 January 2020
Accepted Date: 23 January 2020
Please cite this article as: Küçükkurt S, Kağan Değerliyurt M, Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs?, Journal of Oral and Maxillofacial Surgery (2020), doi: https://doi.org/10.1016/j.joms.2020.01.030. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2020 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs?
Sercan KÜÇÜKKURT, DDS PhD,1* Mehmet Kağan DEĞERLİYURT, DDS PhD,2
1
Assistant Professor, Istanbul Aydın University, Department of Oral and Maxillofacial
Surgery, Istanbul – Turkey 2
Associate Professor, Istanbul Aydın University, Department of Oral and Maxillofacial
Surgery, Istanbul – Turkey
*
Correspondence:
Sercan KÜÇÜKKURT, DDS PhD, [email protected], +90 532 620 55 90, Istanbul Aydın University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, 34295 Istanbul – Turkey
Acknowledgements: none Funding sources: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Declarations of interest: none
AUTHOR CONTRIBUTIONS Conceptualization: KUCUKKURT, DEGERLIYURT Data curation: KUCUKKURT, DEGERLIYURT Formal analysis: KUCUKKURT Funding acquisition: KUCUKKURT Investigation: KUCUKKURT, DEGERLIYURT Methodology: KUCUKKURT, DEGERLIYURT Project administration: KUCUKKURT, DEGERLIYURT Resources: KUCUKKURT, DEGERLIYURT Software: KUCUKKURT Supervision: DEGERLIYURT Validation: KUCUKKURT, DEGERLIYURT Visualization: KUCUKKURT, Writing - original draft: KUCUKKURT Writing - review & editing: DEGERLIYURT
Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs? ABSTRACT Purpose. This study aimed to compare the postoperative pain, edema, patient satisfaction, and operating time between piezosurgery, reciprocal microsaw, and conventional burs in surgically assisted rapid palatal expansion (SARPE) technique for the correction of the transversal maxillary deficiency. The results of this study may help the clinicians minimize the post-operative complaints of patients after SARPE. Material and methods. This randomized single-blind study included patients who underwent SARPE either with piezosurgery (P), reciprocating microsaw (S), or conventional burs (B). In order to determine facial norms and postoperative facial edema, four anatomical distances were measured on the patients’ face using the modified flexible ruler method. The mean facial edema score was determined to evaluate and compare the overall edema among the groups. Two separate visual analog scales (VAS) were used for the assessment of postoperative pain and intra-operative satisfaction among the patients. The duration of the osteotomies was recorded. Intra-group data were statistically analyzed via a t-test while inter-group data were analyzed via a non-parametric Kruskal-Wallis test. Spearman’s correlation was used to evaluate the relationships among the variables. Results. Among the 80 patients, edema (on the 2nd day: P:0.53 ±0.34, S:0.61 ±0.30, B:0.94 ±0.33; p<0.001) and pain (P:2.3 ±0.3, S:3.6 ±0.4, B:3.9 ±0.6; p<0.001) were found to be significant with conventional burs and microsaws, while patient satisfaction (P:8.3 ±0.3, S:5.5 ±0.5, B:5.1 ±0.9; p<0.001) was higher with piezosurgery. However, in the piezosurgery group, the duration of osteotomies was more by 50% (P:16.10 ±3.30, S:11.05 ±2.09, B:11.2 ±2.14; p<0.001). Conclusions. This study shows that piezosurgery is an effective method for minimizing facial edema and patient morbidity and increasing satisfaction during the SARPE procedure. Moreover, the use of conventional bur and saw prolongs the duration of facial edema. Keywords: surgically assisted rapid palatal expansion; palatal expansion technique; piezosurgery; edema; pain; patient satisfaction 1
INTRODUCTION Maxillary transverse deficiency (MTD) is characterized by a narrow maxillary arch, unilateral or bilateral crossbite, high narrow palatal vault, and crowded or misaligned teeth. Single or bilateral MTDs in adults can be skeletally corrected by surgically assisted rapid palatal expansion (SARPE) technique. SARPE is indicated in patients over 15 years of age, having closed craniofacial sutures, and an isolated MTD greater than 5 mm. SARPE focuses on osteotomizing the maxillary sutures in order to relieve the resistance to expansion by orthodontic appliances. 1, 2 Traditionally, conventional burs and microsaws are used for maxillofacial osteotomies. Piezosurgery is a pioneering technique that provides safe and effective osteotomies by employing ultrasonic vibrations, via a polarized piezoceramic, expanding in the direction of and contracting perpendicular to the polarity. Since the device works only on mineralized tissues, it spares the vital soft tissues including the mucosa, nerves, and blood vessels. The indispensable feature of piezosurgery is the micrometric cutting and selective osteotomy, without any risk of osteonecrosis. The main advantages of piezoelectric osteotomies include less surgical trauma, prevention of potential complications, providing a comfortable intraoperative period in addition to less complicated postoperative courses while obtaining reasonable outcomes.3–5 The purpose of this study was to compare the duration of postoperative edema, pain intensity, intraoperative and postoperative patient satisfaction, and duration of surgery in patients who underwent subtotal LeFort I osteotomy, as a part of SARPE, either by conventional burs, microsurgical saws with osteotomes, or piezosurgery under local anesthesia. The investigators hypothesized that there would be no difference in any outcome irrespective of the type of osteotomy technique employed. The study particularly aimed to examine the proclamation that the uniqueness of piezosurgery actually provides an advantage in terms of postoperative edema, pain, and patient satisfaction.
2
MATERIAL AND METHODS A randomized single-blind clinical trial was designed to address the research purpose. The study population comprised all patients referred to Istanbul Aydin University, School of Dentistry, Department of Oral and Maxillofacial Surgery for the evaluation and management of MTD, between May 2015 and September 2018. This study was approved by the Ethics Committee of Gazi University, School of Dentistry. All patients or their parents were informed in detail about the preliminary diagnosis, surgical procedures, and all possible complications. Informed consent from the patients was obtained prior to the study. The inclusion criteria for the study were non-syndromal, skeletally mature patients with an MTD of more than 5 mm, in addition to hypoplasia. Patients were excluded if they were found to have any systemic diseases that would prevent surgical treatment or healing process, bone pathology, history of psychiatric disease, allergies to drugs that would be used in the study and if they were on continuous medication that could affect the outcomes of the study. Also, the patients who did not appear for follow up visits after the surgery were excluded. Since the primary outcome of the study was to compare edema between the three osteotomy techniques, the investigators acquired four facial measurements. The face measurements were made in a resting position, with the patient sitting upright and looking across. In order to perform facial norms and postoperative facial edema measurements, some anatomical points were marked on the right and left sides of the face. The distances utilized for the measurement of facial norms and edema were as follows (Figure 1): 1. Commissura labiorum–Tragus (CT), 2. Angulus mandibula–Lateral canthus (AL), 3. Commissura labiorum–Lateral canthus (CL), 4. Tragus–Sulcus nasolabialis (TS) These distances were measured and recorded by the modified flexible ruler method as described by Neupert et al.6 The measurements were made on both sides of the face for
3
every distance and were recorded by taking the average of the left and right measurements. In order to reduce errors, all measurements were made twice, and the average values were considered. The measurements for the facial norm of the patients were performed before the surgery, and the measurements for facial edema were performed on the 2nd, 7th, 10th, and 14th day of the surgery. A mean facial norm score (MFNS) and mean facial edema score (MFES) were constituted for evaluation and comparison of the overall edema among the groups in an accurate and convenient manner by calculating the arithmetical average of all four facial norm or edema measurements. The secondary outcomes of this study included postoperative pain levels, patient satisfaction, and operating time. Visual Analog Scale (VAS) was used for the evaluation of pain and patient satisfaction after the surgery. In order to assess the pain experienced in the postoperative period and patient satisfaction, two separate scales were prepared that evaluated perceived vibration, noise, operating time, early postoperative pain, and swelling related to the procedure on a horizontal scale of 10 cm. All patients were asked to make a mark on the visual analog scale (VAS) at the first follow-up after the surgery (Day 2). The points marked on the scales were measured in millimeters. The operating time was measured from the initiation of bone osteotomies until the separation of the pterygomaxillary junction. In all patients, the surgery was performed by one of the two surgeons while the other surgeon performed the facial measurements, without being aware of the surgical technique and collected the VAS scores for the assessment of pain and patient satisfaction. The surgical procedure was the same for all patients and was carried out as subtotal LeFort I osteotomy under local anesthesia. Adequate anesthesia was ensured by blocking the related nerves. The dose of the local anesthesia administered was standardized as 5 × 2 mL (40 mg articaine hydrochloride + 0.012 mg epinephrine hydrochloride) for all patients, which was found to be very satisfactory. Since relatively, the most novel technique was piezosurgery, the study was designed with two main groups: experimental (piezosurgery) and standard study groups. The standard study group comprised two subgroups which included conventional burs and microsurgical saw. All the patients referred for evaluation and management of MTD were randomly
4
assigned to either experimental or study groups. Similarly, in the experimental group, the patients were randomly assigned to either conventional bur group or microsaw group. In the conventional rotary bur (BUR) group, maxillary osteotomies were performed with the finest (1 mm) tungsten-carbide round and fissure burs (Hager & Meisinger GmbH, Fissure: HM 31 010, Round: HM 141 023, Neuss, Germany). Brand new round and fissure burs were used for every patient. In the patients who underwent surgery with a microsaw (SAW group) (W&H GmbH, Surgical Saw S–8 R, Bürmoos, Austria), maxillary osteotomies were performed with reciprocal micro-saw tips (0.35mm). In the piezosurgery (PIEZO) group (Mectron S.P.A., Piezosurgery®, Genoa, Italia), the maxillary osteotomies were performed with OT7 inserts while the pterygomaxillary osteotomies were performed with OT8R or OT8L angled inserts (0.75 mm) (Figure 2). Midline osteotomies were made with OT7 inserts in the PIEZO group (if necessary, at the end, segments were separated by horizontal movements with the help of an osteotome without the use of hammers), in the SAW and BUR groups osteotomies were made with microsaw and burs superficially and deepened with the help of thin osteotomes and hammer. Nasal septum and lateral nasal walls were also osteotomized. For all osteotomy procedures, the devices were mounted with a saline carrier, and a peristaltic pump and the maximum amount of irrigation that was allowed by the devices were used in order to prevent excessive heat production during osteotomies and to increase the visibility of the operating area. In the BUR and SAW groups, the pterygoid plates were separated using pterygoid osteotomes, while in the PIEZO group, this was done by angled piezosurgery tips. All surgical procedures were carried out by the same operator. The duration of osteotomies was recorded with a stopwatch and rounded off to the nearest whole number. After the surgery, 500 mg amoxicillin, 500 mg paracetamol, and 0.12% chlorhexidine gluconate were routinely prescribed three times a day. All the patients were discharged after the usual postoperative recommendations. Considering that the effectiveness of ice application is controversial
7
and that all patients cannot apply ice identically; it was not
prescribed postoperatively. The patients were advised not to use any analgesics other than the prescribed one, and none of the patients were administered pre- or post-steroid injections. Statistical analysis was performed using STATA 14.1 (College Station, Texas, USA). Mean and standard deviations were reported as mean ±standard deviation. The basic continuous 5
variables were subjected to a t-test. The robustness of the model was evaluated by the nonparametric Kruskal-Wallis tests. Basic categorical variables were tested via Fisher’s exact test. The differences in outcome variables were determined by repeated measurements and were therefore tested using random effect models. Spearman’s correlation was used to evaluate relationships between outcome variables of the study. Confidence intervals corresponding to 95% were reported. The required sample size was estimated using the Power and Sample Size Calculation (PS Version 3.0.43) software. At a given two-sided significance level of α = 5%, a standardized effect of 1 with a power of 1 − β = 80% should be demonstrated by the test. For a solid basis of measurement data, a study population of at least 20 per group (PIEZO: 40, SAW and BUR Groups: 20) was considered necessary.
6
RESULTS The study included 80 patients (40 females and 40 males), aged between 15 and 34 years (20.6 ±4.7) with complete skeletal development, who were diagnosed with MTD (> 5 mm) as per the posteroanterior radiographs. The edema levels, VAS scores for postoperative pain and patient satisfaction assessment, the total duration of osteotomy and correlation between the variables were analyzed statistically. (Tables 1-3) Edema on the 2nd Day The quantitative and statistical comparisons between pre-operative MFNS and postoperative MFES on the 2nd day are shown in Table 3 and Figure 3. The differences in MFES between the PIEZO and BUR groups or the BUR and SAW groups were statistically significant while it was nonsignificant between the PIEZO and SAW groups. Though quantitatively, the least edema appeared to be in the PIEZO group, the difference between the PIEZO and SAW groups was mild and statistically nonsignificant while the edema was the highest in the BUR group. In the AL measurement, the PIEZO group had a significantly lower score as compared to the BUR group (p=0.003). The difference in TS measurements between the PIEZO and BUR groups was also statistically significant (p=0.011). Edema on the 7th Day Quantitative and statistical intragroup analyses of the decreases in the MFES in all groups between pre-op MFNS and 7th day MFES are shown in Table 3. The difference in MFES was statistically significant between the PIEZO and BUR (p<0.001) or PIEZO and SAW (p=0.015) groups, while that between the BUR and SAW groups was nonsignificant (p=0.315). The difference between the PIEZO and BUR groups was statistically significant in all measurements except CL (p=0.227), while the differences between the BUR and SAW groups were statistically nonsignificant. The only statistically significant difference between the PIEZO and SAW groups was the AL measurement (p=0.007). Similar to the 2nd day, the measurements were also found to be quantitatively lower in the PIEZO group (%2,1) on the 7th day (Figure 3).
7
Edema on the 10th Day The total edema measured on the 10th postoperative day in MFES and statistical analysis among the groups are shown in Table 3. Although considering the MFES, the least edema was found in the PIEZO group on the 10th day; only the difference in MFES between the PIEZO and BUR groups was statistically significant (P<0.001). On the 10th day, the difference between MFNS and MFES was only 0.6% for the PIEZO group, though it was still statistically significant (p=0.001). The maximum decrease in overall edema was seen in BUR group (6.8%) between the 2nd and 10th days; however, the maximal facial edema was still in the BUR group (2.1%) (Figure 3) Edema on the 14th Day In all four facial measurements, the differences among groups and the differences between the PIEZO and BUR or BUR and SAW groups were statistically significant, while those between the PIEZO and SAW groups were not. Regarding the difference between MFNS and MFES on the 14th day, the least edema was observed in the PIEZO group (%0,1) and the difference was statistically nonsignificant in this group (p=0.577), which indicates that the level of edema in the PIEZO group was almost near to that of the MFNS. The edema in the SAW (%0,7) and BUR (%1,0) group was still persistent and statistically significant (p=0.001) (Figure 3). Considering the MFES, the differences between the PIEZO and BUR groups (p<0.001), or PIEZO and SAW groups (p=0.005) were statistically significant while those between BUR and SAW group were not (p=0.099) (Table 3). The decrease in overall edema between the 10th and 14th days was statistically nonsignificant in the PIEZO group (p=0.199) while it was significant in the SAW and BUR groups (p<0.001). VAS Scores The mean VAS score for pain in the PIEZO group was lower than that in the other groups (p<0.05). Similarly, the comparisons between the PIEZO and BUR or the PIEZO and SAW groups were statistically significant. Postoperatively, the patients experienced significantly lesser pain by piezosurgery compared to the other two methods (p<0.05). There was no statistically significant difference between the SAW and BUR groups (p=0.855) (Table 1). Patient satisfaction was evaluated for perceived vibration, noise, operating time, early postoperative pain, and swelling related to the procedure. The patient satisfaction obtained 8
by piezosurgery was significantly higher (p<0.01). There was no statistically significant difference between the SAW and BUR groups (p=0.741). (Table 1) Operating time The average time difference between the groups was found to be statistically significant. In the PIEZO group, osteotomy took a significantly longer time than the other methods (p<0.05). On the other hand, there was no statistically significant difference between the SAW and BUR groups (p=0.620). Correlation between MFES with secondary variables Spearman’s correlation test was performed to examine if MFES and secondary study variables (VAS score for pain, VAS score for patient satisfaction, and operating time) were correlated. Pertaining to the results, edema was not found to be correlated with any of the mentioned variables (Table 2). Yet, the VAS score for pain and patient satisfaction were observed to be strongly correlated (p<0,001).
9
DISCUSSION This study was performed with the purpose of comparing the edema, postoperative pain, patient satisfaction, and operating time in the SARPE technique, as performed with piezosurgery or reciprocal microsaw and conventional burs with osteotomes. The investigators hypothesized that there would be no difference in any of the outcomes between the groups. However, the results revealed that edema was lesser in the PIEZO group and resolved in a shorter duration. The patients experienced significantly less postoperative pain during piezosurgery and the patient satisfaction obtained by piezosurgery was significantly higher in comparison to the other two methods. However, osteotomy took a significantly longer time in the PIEZO group. Any surgical trauma stimulates a cellular response and begins the process of digestion to eliminate the necrotic tissues. Excessive tissue damage and necrotic cells at the surgical site result in an intense inflammatory response, ensuring a high level of edema. Piezosurgery offers some crucial advantages; low bone injury resulting from the absence of coagulation necrosis and micrometric cutting ability are two significant characteristics of piezosurgery. It also offers better hemostasis, which reduces the risk of edema altogether.5, 8–10 The authors investigated if the thickness of the maxillary osteotomy line could be the primary factor determining the level of postoperative facial edema. A comparison of the average edema level among groups in the study indicated that this assertion is controversial since the level of facial edema in the SAW group was more than that in the PIEZO group, considering that reciprocal microsaw (0.35 mm) is thinner than the piezosurgery inserts (0.75 mm). Besides, the BUR group was still the one with considerable facial edema suggesting that the osteotomy thickness is critical but it is not the only factor. Although the burs were the thickest (1 mm) in the BUR group, the comparison of the edema level between the SAW and BUR groups was not statistically significant at the second postoperative day. The results of the present study may provoke new research to identify whether the hemostatic features of piezosurgery, low tissue damage resulting from the absence of coagulation necrosis and better survival of the bone cells, which may be the significant factors for low edema, might really have an effect on the reduced edema. The results of this study suggest that, although not definitive, the features of piezosurgery mentioned above, might be responsible for the low levels of edema after subtotal LeFort I 10
osteotomy in the PIEZO group in comparison to the BUR and SAW groups. Preti et al.11 found that neo-osteogenesis was consistently more active in bony samples from implant sites, which had been prepared via piezosurgery rather than by conventional burs. Earlier research has also shown that there was an early increase in bone morphogenetic protein–4 (BMP–4) and transforming growth factor–2 (TGF–2) proteins, and that fewer pro-inflammatory cytokines were released in bone with piezosurgery. In this study, the fastest resolution of edema occurred in the PIEZO group. Along the entire post-operative course, the PIEZO group exhibited the minimum edema as compared to the other groups. In terms of the MFES on day 14, edema almost disappeared in the PIEZO group while it decreased slowly in the BUR and SAW groups. This observation may suggest that piezosurgery is more effective in the early phase of bone healing by inducing an early increase in BMP and TGF, controlling the inflammatory reactions in a better manner, stimulating the remodeling of the bone and by inducing a faster edema resolution, postoperatively. Further histological animal studies with a similar design may clarify these assumptions. Spinelli et al.12 reported that piezosurgery gives better results in terms of intraoperative blood loss, postoperative edema, hematoma, and nerve damage as compared to the conventional techniques in orthognathic surgical procedures, thus helping the surgeon achieve patient satisfaction. Landes et al.13 in anterior iliac bone graft harvesting procedure and Robiony et al.14 in rhinoplasty surgeries also obtained better results with piezosurgery as compared to the conventional methods. In a systematic review and meta-analysis, AlMoraissi et al.15 concluded that piezosurgery significantly reduces the occurrence of postoperative pain and edema, in 3rd molar surgeries. The results of the present study concur with the other studies comparing conventional techniques with piezosurgery in terms of edema and pain. The patients experienced significantly lesser pain in piezosurgery. The authors also noted that, in terms of the MFES, edema was lower all along the post-operative course and returned to normal levels faster with piezosurgery. Post-operative edema is the most common complaint following facial surgeries. Although the patients do not feel much discomfort or pain associated with their facial appearance, the postoperative edema is socially disturbing and frightening.16 The relationship between preoperative patient expectations and postoperative patient satisfaction in orthognathic surgery has been evaluated in some studies.17, 18 Kiyak et al.17 reported that patients with 11
less pain and swelling than expected were the most satisfied ones or vice versa. Rana et al.19 compared piezosurgery and SAW with osteotomes in SARPE patients and reported that the swelling was not intense and disappeared quickly in both the groups. They concluded that postoperative pain did not make a statistically significant difference between the two groups; however, patient satisfaction was statistically higher in the piezosurgery group. Considering lesser pain, even though contrary to Rana et al.19, and edema after SARPE with piezosurgery, the results of this study support the findings of Kiyak et al.17 and Rana et al.19 The authors concluded that neither pain nor patient satisfaction was correlated with edema; even though pain and patient satisfaction were strongly correlated with each other. These results partially support the findings of Kiyak et al.17, suggesting that the most satisfied patients were the ones with lesser postoperative pain, regardless of the level of edema. Robiony et al.20 reported that patient comfort increases with piezosurgery in SARPE under local anesthesia as there is no need for osteotome and hammer during this procedure. Laino et al.21 indicated that SARPE can be safely performed under local anesthesia and that the intra- and post-operative discomfort levels of the procedure are similar to other procedures, typically performed under local anesthesia. This study aimed to compare the use of conventional methods and piezosurgery in terms of intra-operative patient satisfaction, which makes the local anesthesia a perfect choice. No patient complained of pain during the surgery, though, all patients in the BUR and SAW groups reported that the use of pterygoid osteotomes and hammers was psychologically disturbing. 19 Despite the lesser vibrations and lower levels of disturbing sounds, the absence of hammering should be considered as one of the most important factors increasing patient satisfaction. This may explain the statistical difference obtained among the groups in this study. Many authors have stated that the most significant disadvantage of piezosurgery is the time factor and osteotomies in orthognathic surgeries take a longer time than conventional osteotomies due to the relatively low cutting efficiency of piezosurgery. However, studies have also emphasized that piezosurgery is a better alternative compared to the conventional methods when all other advantages, especially its low risk of damage to the neighboring soft tissues, are considered.10, 19, 22–25 In the present study, osteotomies with piezosurgery took 49% more time as compared to the BUR group and 40% more time than that in the SAW groups. However, a longer operating time was expected since the pterygomaxillary 12
disjunction was performed with angled piezosurgery tips, which prolongs the duration. These differences were statistically significant; although, the clinical importance of this difference is controversial. Rotary tools convert electrical or air pressure energy into a mechanical cutting function by use of sharp burs or saws. These devices produce a significant amount of heat and may lead to marginal osteonecrosis, thus altering or delaying the healing response. Low rotation speed reduces not only the amount of heat generated but also the cutting efficiency. The presence of macro vibrations makes the instrument prone to slipping, thus making it less manageable and difficult to be used for cutting of different anatomical regions. They have an inevitable risk of damaging the surrounding soft tissues such as nerves, veins, and mucosa.5, 8, 26
The safety of the use of a reciprocating SAW or similar techniques at specific sites with a high risk of soft tissue damage such as the pterygomaxillary junctions is controversial. Some authors advocate that even the use of curved pterygoid osteotomies should be abandoned as it may damage the content of pterygopalatine fossa, resulting in high pterygoid plate fractures or fractures extending to the skull base and orbit.27, 28 In contrast, Ueki et al.29 and Robiony et al.20 reported that ultrasonic devices advantageously provide a safe way of relieving pterygomaxillary junction without damaging the surrounding soft tissues. The authors of this study experienced that the selective cutting feature of piezosurgery helps the surgeon preserve the soft tissues in critical areas, and the device can be handled conveniently thereby allowing a smooth relief of the pterygomaxillary junction with exceptionally controlled bleeding, possibly due to its cavitation effect. Mild to moderate bleeding was observed in ten patients (25%) after releasing the pterygomaxillary junction by curved osteotomes; nevertheless, no bleeding occurred when it was released by piezosurgery. This benefit can be attributed to the protection of the intense vascular network of the pterygomaxillary region by piezosurgery vibrations and the effect of cavitation, causing coagulation in small vessels. The present study supports other studies reporting the fact that relieving the pterygomaxillary junction with piezosurgery is highly safe and predictable.
13
There is no standard procedure to quantify the level of edema. Although various methods (calipers, facial arches, photographic or stereophotographic methods, computed tomography, magnetic resonance imaging, etc.) have been proposed to measure the threedimensional facial swelling or edema, none of them is accurate.30 In this study, a modified flexible ruler method, proposed by Neupert et al.6 was utilized. The choice of the ruler method to quantify the level of edema could be attributed as a weakness, as this method does not precisely determine the volume of soft facial tissues like that in computed tomography or magnetic resonance imaging. However, it is non-invasive, simple, effective, and time-saving. This still offers some quantitative estimates suitable for comparative analysis of changes in the soft tissue contour. Unfortunately, the effect of the method in relieving pterygomaxillary junction could not be properly evaluated on facial edema using the ruler method, which was another weakness of this study. The authors could only suggest that separation of the pterygomaxillary junction with piezosurgery possibly produces less swelling in the early post-operative phase due to the effect of cavitation causing coagulation. Further studies with a similar design that would use CT or MRI to quantify the effect of the method to relieve pterygoid junction on facial edema might unveil the effect of this confounding variable, which would enable the surgeons to take it into account correctly.
14
CONCLUSIONS The SARPE procedure can comfortably be performed under local anesthesia, and the edema level after osteotomies is statistically lower in piezosurgery and microsaw groups as compared to that in conventional burs. Further, edema resolves faster with piezosurgery than that with conventional burs and microsaw. In piezosurgery, the level of pain is lower. It was observed that piezosurgery increases the satisfaction and cooperation of patients by preventing and inducing lesser psychological trauma, caused by the use of osteotome and hammer. As a disadvantage, osteotomies performed by piezosurgery took 50% longer time. Further, no significant differences were found between the SAW and the BUR groups in terms of operating time, VAS, and edema level; however, healing took more time in the BUR and SAW groups due to persistent edema. The present study determined that piezosurgery allows the release of the pterygomaxillary junction with excellent bleeding control in comparison to the curved pterygoid osteotomes.
15
REFERENCES 1. Anttila A, Finne K, Keski-Nisula K, Somppi M, Panula K, Peltomaki T: Feasibility and longterm stability of surgically assisted rapid maxillary expansion with lateral osteotomy. Eur J Orthod 26:391, 2004 2. Koudstaal MJ, Poort LJ, van der Wal KG, Wolvius EB, Prahl-Andersen B, Schulten AJ: Surgically assisted rapid maxillary expansion (SARME): a review of the literature. Int J Oral Maxillofac Surg 34:709, 2005 3. Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP: Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent 25:543, 2005 4. Gruber RM, Kramer FJ, Merten HA, Schliephake H: Ultrasonic surgery--an alternative way in orthognathic surgery of the mandible. A pilot study. Int J Oral Maxillofac Surg 34:590, 2005 5. Schaller BJ, Gruber R, Merten HA, Kruschat T, Schliephake H, Buchfelder M, Ludwig HC: Piezoelectric bone surgery: a revolutionary technique for minimally invasive surgery in cranial base and spinal surgery? Technical note. Neurosurgery 57:E410; discussion E410, 2005 6. Neupert EA, third, Lee JW, Philput CB, Gordon JR: Evaluation of dexamethasone for reduction of postsurgical sequelae of third molar removal. J Oral Maxillofac Surg 50:1177, 1992 7. van der Westhuijzen AJ, Becker PJ, Morkel J, Roelse JA: A randomized observer blind comparison of bilateral facial ice pack therapy with no ice therapy following third molar surgery. Int J Oral Maxillofac Surg 34:281, 2005 8. Vercellotti T, Pollack AS: A new bone surgery device: sinus grafting and periodontal surgery. Compend Contin Educ Dent 27:319, 2006 9. Leclercq P, Zenati C, Amr S, Dohan DM: Ultrasonic bone cut part 1: State-of-the-art technologies and common applications. J Oral Maxillofac Surg 66:177, 2008 10. Bertossi D, Lucchese A, Albanese M, Turra M, Faccioni F, Nocini P, Rodriguez YBR: Piezosurgery versus conventional osteotomy in orthognathic surgery: a paradigm shift in treatment. J Craniofac Surg 24:1763, 2013
16
11. Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G: Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol 78:716, 2007 12. Spinelli G, Lazzeri D, Conti M, Agostini T, Mannelli G: Comparison of piezosurgery and traditional saw in bimaxillary orthognathic surgery. J Craniomaxillofac Surg 42:1211, 2014 13. Landes CA, Stubinger S, Laudemann K, Rieger J, Sader R: Bone harvesting at the anterior iliac crest using piezoosteotomy versus conventional open harvesting: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 105:e19, 2008 14. Robiony M, Toro C, Costa F, Sembronio S, Polini F, Politi M: Piezosurgery: a new method for osteotomies in rhinoplasty. J Craniofac Surg 18:1098, 2007 15. Al-Moraissi EA, Elmansi YA, Al-Sharaee YA, Alrmali AE, Alkhutari AS: Does the piezoelectric surgical technique produce fewer postoperative sequelae after lower third molar surgery than conventional rotary instruments? A systematic review and meta analysis. Int J Oral Maxillofac Surg 45:383, 2016 16. Yucel OT: Which type of osteotomy for edema and ecchymosis: external or internal? Ann Plast Surg 55:587, 2005 17. Kiyak HA, Vitaliano PP, Crinean J: Patients' expectations as predictors of orthognathic surgery outcomes. Health Psychol 7:251, 1988 18. Neal CE, Kiyak HA: Patient perceptions of pain, paresthesia, and swelling after orthognathic surgery. Int J Adult Orthodon Orthognath Surg 6:169, 1991 19. Rana M, Gellrich NC, Rana M, Piffko J, Kater W: Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy – a randomized prospective trial. Trials 14:49, 2013 20. Robiony M, Polini F, Costa F, Zerman N, Politi M: Ultrasonic bone cutting for surgically assisted rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg 36:267, 2007 21. Laino L, Troiano G, Dioguardi M, Perillo L, Laino G, Lo Muzio L, Cicciu M: Patient Discomfort During and After Surgically Assisted Rapid Maxillary Expansion Under Local Anaesthesia. J Craniofac Surg 27:772, 2016
17
22. Olate S, Pozzer L, Unibazo A, Huentequeo-Molina C, Martinez F, de Moraes M: LeFort I segmented osteotomy experience with piezosurgery in orthognathic surgery. Int J Clin Exp Med 7:2092, 2014 23. Akbar Z, Saleem H, Ahmed W: Critical Analysis of Piezoelectric Surgery with Oscillating Saw in Bimaxillary Orthognathic Surgery. J Coll Physicians Surg Pak 27:348, 2017 24. Mohlhenrich SC, Ayoub N, Fritz U, Prescher A, Holzle F, Modabber A: Evaluation of ultrasonic and conventional surgical techniques for genioplasty combined with two different osteosynthesis plates: a cadaveric study. Clin Oral Investig 21:2437, 2017 25. Bertossi D, Albanese M, Nocini R, Mortellaro C, Kumar N, Nocini PF: Osteotomy in Genioplasty by Piezosurgery. J Craniofac Surg, 2018 26. Kerawala CJ, Martin IC, Allan W, Williams ED: The effects of operator technique and bur design on temperature during osseous preparation for osteosynthesis self-tapping screws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88:145, 1999 27. Robinson PP, Hendy CW: Pterygoid plate fractures caused by the Le Fort I osteotomy. Br J Oral Maxillofac Surg 24:198, 1986 28.
Lanigan DT, Guest P: Alternative approaches to pterygomaxillary separation. Int J Oral
Maxillofac Surg 22:131, 1993 29. Ueki K, Nakagawa K, Marukawa K, Yamamoto E: Le Fort I osteotomy using an ultrasonic bone curette to fracture the pterygoid plates. J Craniomaxillofac Surg 32:381, 2004 30. Weber CR, Griffin JM: Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg 52:35, 1994
18
FIGURE LEGENDS Figure 1. Marked anatomical points to perform facial norms and postoperative facial edema measurements. White line: Commissura labiorum–Tragus (CT), Red line: Angulus mandibula–Lateral canthus (AL), Blue line: Commissura labiorum–Lateral canthus (CL) Black line: Tragus–Sulcus nasolabialis (TS). Figure 2. Separation of pterygomaxillary junction by piezosurgery Figure 3. Changes in the percentage of the edema levels on post-operative 2nd, 7th, 10th, and 14th days (Paired t-test.)
19
TABLES (PIEZO-BUR-SAW) Mean
SD
(PIEZO-
(PIEZO-
(BUR-
BUR)
SAW)
SAW)
P
P
P
P
<0.001
0.005
0.001
0.855
VAS SCORES FOR PAIN (MM) PIEZO
2.3
0.3
BUR
3.6
0.4
SAW
3.9
0.6
VAS SCORES FOR POST OPERATIVE PATIENT SATISFACTION (MM) PIEZO
8.3
0.3
BUR
5.5
0.5
SAW
5.1
0.9
<0.01
0.05
0.01
0.741
0.0001
0.0001
0.0001
0.620
DURATION OF OPERATION (MIN) PIEZO
16.10
±3.30
BUR
11.05
±2.09
SAW
11.20
±2.14
Table 1. The quantitative and statistical analysis of VAS Scores (in millimeters) of the patients for pain, post-operative satisfaction, and duration of operation (Minutes) among the groups. (SD: Standard deviation)
20
MEAN FACIAL EDEMA SCORES Day 2
Day 7
Day 10
Day 14
R
-,162
-,137
-,190
-.238
P
,150
,225
,091
,034
VAS SCORE FOR POST OPERATIVE
R
,117
,087
,149
,188
PATIENT SATISFACTION (MM)
P
,302
,445
,186
,095
DURATION OF OPERATION (MIN)
R
-,067
-,072
-,032
-,020
P
,554
,526
,779
,859
VAS SCORE FOR PAIN (MM)
Table 2. Mean facial edema scores versus secondary study variables. (r: Pearson’s correlation coefficient)
21
Pre-op vs. Day 2
Pre-op vs. Day 7
Pre-op vs. Day 10
Pre-op vs. Day 14
MEAN FACIAL
PIEZO-
PIEZO-
PIEZO-
BUR-
EDEMA SCORES
SAW-
BUR
SAW
SAW
(MFES)
BUR p
p
p
p
MEAN
SD
(mm)
(mm)
PIEZO
0.53
0.34
0.000
0.000
0.373
0.002
SAW
0.61
0.30
*
**
**
**
BUR
0.94
0.33
PIEZO
0.21
0.25
0.001
0.000
0.015
0.315
SAW
0.35
0.20
***
****
****
****
BUR
0.42
0.21
PIEZO
0.06
0.19
0.000
0.000
0.063
0.064
SAW
0.15
0.13
***
****
****
****
BUR
0.20
0.10
PIEZO
0,02
0.13
0.000
0.000
0.005
0.099
SAW
0.06
0.07
***
****
****
****
BUR
0.10
0.07
* ANOVA, ** Independent t-test, ***Kruskal Wallis test b, **** Mann Whitney U test Table 3. The quantitative and statistical analysis of differences in mean facial edema score (MFES) among the groups in the post-operative 2nd, 7th, 10th, and 14th days. (SD: Standard deviation)
22
S0278-2391(20)30106-3
DOI:
https://doi.org/10.1016/j.joms.2020.01.030
Reference:
YJOMS 59066
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 22 April 2019 Revised Date:
22 January 2020
Accepted Date: 23 January 2020
Please cite this article as: Küçükkurt S, Kağan Değerliyurt M, Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs?, Journal of Oral and Maxillofacial Surgery (2020), doi: https://doi.org/10.1016/j.joms.2020.01.030. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2020 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs?
Sercan KÜÇÜKKURT, DDS PhD,1* Mehmet Kağan DEĞERLİYURT, DDS PhD,2
1
Assistant Professor, Istanbul Aydın University, Department of Oral and Maxillofacial
Surgery, Istanbul – Turkey 2
Associate Professor, Istanbul Aydın University, Department of Oral and Maxillofacial
Surgery, Istanbul – Turkey
*
Correspondence:
Sercan KÜÇÜKKURT, DDS PhD, [email protected], +90 532 620 55 90, Istanbul Aydın University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, 34295 Istanbul – Turkey
Acknowledgements: none Funding sources: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Declarations of interest: none
AUTHOR CONTRIBUTIONS Conceptualization: KUCUKKURT, DEGERLIYURT Data curation: KUCUKKURT, DEGERLIYURT Formal analysis: KUCUKKURT Funding acquisition: KUCUKKURT Investigation: KUCUKKURT, DEGERLIYURT Methodology: KUCUKKURT, DEGERLIYURT Project administration: KUCUKKURT, DEGERLIYURT Resources: KUCUKKURT, DEGERLIYURT Software: KUCUKKURT Supervision: DEGERLIYURT Validation: KUCUKKURT, DEGERLIYURT Visualization: KUCUKKURT, Writing - original draft: KUCUKKURT Writing - review & editing: DEGERLIYURT
Does piezosurgery decrease patient morbidity in surgically assisted rapid palatal expansion (SARPE) compared to saw and burs? ABSTRACT Purpose. This study aimed to compare the postoperative pain, edema, patient satisfaction, and operating time between piezosurgery, reciprocal microsaw, and conventional burs in surgically assisted rapid palatal expansion (SARPE) technique for the correction of the transversal maxillary deficiency. The results of this study may help the clinicians minimize the post-operative complaints of patients after SARPE. Material and methods. This randomized single-blind study included patients who underwent SARPE either with piezosurgery (P), reciprocating microsaw (S), or conventional burs (B). In order to determine facial norms and postoperative facial edema, four anatomical distances were measured on the patients’ face using the modified flexible ruler method. The mean facial edema score was determined to evaluate and compare the overall edema among the groups. Two separate visual analog scales (VAS) were used for the assessment of postoperative pain and intra-operative satisfaction among the patients. The duration of the osteotomies was recorded. Intra-group data were statistically analyzed via a t-test while inter-group data were analyzed via a non-parametric Kruskal-Wallis test. Spearman’s correlation was used to evaluate the relationships among the variables. Results. Among the 80 patients, edema (on the 2nd day: P:0.53 ±0.34, S:0.61 ±0.30, B:0.94 ±0.33; p<0.001) and pain (P:2.3 ±0.3, S:3.6 ±0.4, B:3.9 ±0.6; p<0.001) were found to be significant with conventional burs and microsaws, while patient satisfaction (P:8.3 ±0.3, S:5.5 ±0.5, B:5.1 ±0.9; p<0.001) was higher with piezosurgery. However, in the piezosurgery group, the duration of osteotomies was more by 50% (P:16.10 ±3.30, S:11.05 ±2.09, B:11.2 ±2.14; p<0.001). Conclusions. This study shows that piezosurgery is an effective method for minimizing facial edema and patient morbidity and increasing satisfaction during the SARPE procedure. Moreover, the use of conventional bur and saw prolongs the duration of facial edema. Keywords: surgically assisted rapid palatal expansion; palatal expansion technique; piezosurgery; edema; pain; patient satisfaction 1
INTRODUCTION Maxillary transverse deficiency (MTD) is characterized by a narrow maxillary arch, unilateral or bilateral crossbite, high narrow palatal vault, and crowded or misaligned teeth. Single or bilateral MTDs in adults can be skeletally corrected by surgically assisted rapid palatal expansion (SARPE) technique. SARPE is indicated in patients over 15 years of age, having closed craniofacial sutures, and an isolated MTD greater than 5 mm. SARPE focuses on osteotomizing the maxillary sutures in order to relieve the resistance to expansion by orthodontic appliances. 1, 2 Traditionally, conventional burs and microsaws are used for maxillofacial osteotomies. Piezosurgery is a pioneering technique that provides safe and effective osteotomies by employing ultrasonic vibrations, via a polarized piezoceramic, expanding in the direction of and contracting perpendicular to the polarity. Since the device works only on mineralized tissues, it spares the vital soft tissues including the mucosa, nerves, and blood vessels. The indispensable feature of piezosurgery is the micrometric cutting and selective osteotomy, without any risk of osteonecrosis. The main advantages of piezoelectric osteotomies include less surgical trauma, prevention of potential complications, providing a comfortable intraoperative period in addition to less complicated postoperative courses while obtaining reasonable outcomes.3–5 The purpose of this study was to compare the duration of postoperative edema, pain intensity, intraoperative and postoperative patient satisfaction, and duration of surgery in patients who underwent subtotal LeFort I osteotomy, as a part of SARPE, either by conventional burs, microsurgical saws with osteotomes, or piezosurgery under local anesthesia. The investigators hypothesized that there would be no difference in any outcome irrespective of the type of osteotomy technique employed. The study particularly aimed to examine the proclamation that the uniqueness of piezosurgery actually provides an advantage in terms of postoperative edema, pain, and patient satisfaction.
2
MATERIAL AND METHODS A randomized single-blind clinical trial was designed to address the research purpose. The study population comprised all patients referred to Istanbul Aydin University, School of Dentistry, Department of Oral and Maxillofacial Surgery for the evaluation and management of MTD, between May 2015 and September 2018. This study was approved by the Ethics Committee of Gazi University, School of Dentistry. All patients or their parents were informed in detail about the preliminary diagnosis, surgical procedures, and all possible complications. Informed consent from the patients was obtained prior to the study. The inclusion criteria for the study were non-syndromal, skeletally mature patients with an MTD of more than 5 mm, in addition to hypoplasia. Patients were excluded if they were found to have any systemic diseases that would prevent surgical treatment or healing process, bone pathology, history of psychiatric disease, allergies to drugs that would be used in the study and if they were on continuous medication that could affect the outcomes of the study. Also, the patients who did not appear for follow up visits after the surgery were excluded. Since the primary outcome of the study was to compare edema between the three osteotomy techniques, the investigators acquired four facial measurements. The face measurements were made in a resting position, with the patient sitting upright and looking across. In order to perform facial norms and postoperative facial edema measurements, some anatomical points were marked on the right and left sides of the face. The distances utilized for the measurement of facial norms and edema were as follows (Figure 1): 1. Commissura labiorum–Tragus (CT), 2. Angulus mandibula–Lateral canthus (AL), 3. Commissura labiorum–Lateral canthus (CL), 4. Tragus–Sulcus nasolabialis (TS) These distances were measured and recorded by the modified flexible ruler method as described by Neupert et al.6 The measurements were made on both sides of the face for
3
every distance and were recorded by taking the average of the left and right measurements. In order to reduce errors, all measurements were made twice, and the average values were considered. The measurements for the facial norm of the patients were performed before the surgery, and the measurements for facial edema were performed on the 2nd, 7th, 10th, and 14th day of the surgery. A mean facial norm score (MFNS) and mean facial edema score (MFES) were constituted for evaluation and comparison of the overall edema among the groups in an accurate and convenient manner by calculating the arithmetical average of all four facial norm or edema measurements. The secondary outcomes of this study included postoperative pain levels, patient satisfaction, and operating time. Visual Analog Scale (VAS) was used for the evaluation of pain and patient satisfaction after the surgery. In order to assess the pain experienced in the postoperative period and patient satisfaction, two separate scales were prepared that evaluated perceived vibration, noise, operating time, early postoperative pain, and swelling related to the procedure on a horizontal scale of 10 cm. All patients were asked to make a mark on the visual analog scale (VAS) at the first follow-up after the surgery (Day 2). The points marked on the scales were measured in millimeters. The operating time was measured from the initiation of bone osteotomies until the separation of the pterygomaxillary junction. In all patients, the surgery was performed by one of the two surgeons while the other surgeon performed the facial measurements, without being aware of the surgical technique and collected the VAS scores for the assessment of pain and patient satisfaction. The surgical procedure was the same for all patients and was carried out as subtotal LeFort I osteotomy under local anesthesia. Adequate anesthesia was ensured by blocking the related nerves. The dose of the local anesthesia administered was standardized as 5 × 2 mL (40 mg articaine hydrochloride + 0.012 mg epinephrine hydrochloride) for all patients, which was found to be very satisfactory. Since relatively, the most novel technique was piezosurgery, the study was designed with two main groups: experimental (piezosurgery) and standard study groups. The standard study group comprised two subgroups which included conventional burs and microsurgical saw. All the patients referred for evaluation and management of MTD were randomly
4
assigned to either experimental or study groups. Similarly, in the experimental group, the patients were randomly assigned to either conventional bur group or microsaw group. In the conventional rotary bur (BUR) group, maxillary osteotomies were performed with the finest (1 mm) tungsten-carbide round and fissure burs (Hager & Meisinger GmbH, Fissure: HM 31 010, Round: HM 141 023, Neuss, Germany). Brand new round and fissure burs were used for every patient. In the patients who underwent surgery with a microsaw (SAW group) (W&H GmbH, Surgical Saw S–8 R, Bürmoos, Austria), maxillary osteotomies were performed with reciprocal micro-saw tips (0.35mm). In the piezosurgery (PIEZO) group (Mectron S.P.A., Piezosurgery®, Genoa, Italia), the maxillary osteotomies were performed with OT7 inserts while the pterygomaxillary osteotomies were performed with OT8R or OT8L angled inserts (0.75 mm) (Figure 2). Midline osteotomies were made with OT7 inserts in the PIEZO group (if necessary, at the end, segments were separated by horizontal movements with the help of an osteotome without the use of hammers), in the SAW and BUR groups osteotomies were made with microsaw and burs superficially and deepened with the help of thin osteotomes and hammer. Nasal septum and lateral nasal walls were also osteotomized. For all osteotomy procedures, the devices were mounted with a saline carrier, and a peristaltic pump and the maximum amount of irrigation that was allowed by the devices were used in order to prevent excessive heat production during osteotomies and to increase the visibility of the operating area. In the BUR and SAW groups, the pterygoid plates were separated using pterygoid osteotomes, while in the PIEZO group, this was done by angled piezosurgery tips. All surgical procedures were carried out by the same operator. The duration of osteotomies was recorded with a stopwatch and rounded off to the nearest whole number. After the surgery, 500 mg amoxicillin, 500 mg paracetamol, and 0.12% chlorhexidine gluconate were routinely prescribed three times a day. All the patients were discharged after the usual postoperative recommendations. Considering that the effectiveness of ice application is controversial
7
and that all patients cannot apply ice identically; it was not
prescribed postoperatively. The patients were advised not to use any analgesics other than the prescribed one, and none of the patients were administered pre- or post-steroid injections. Statistical analysis was performed using STATA 14.1 (College Station, Texas, USA). Mean and standard deviations were reported as mean ±standard deviation. The basic continuous 5
variables were subjected to a t-test. The robustness of the model was evaluated by the nonparametric Kruskal-Wallis tests. Basic categorical variables were tested via Fisher’s exact test. The differences in outcome variables were determined by repeated measurements and were therefore tested using random effect models. Spearman’s correlation was used to evaluate relationships between outcome variables of the study. Confidence intervals corresponding to 95% were reported. The required sample size was estimated using the Power and Sample Size Calculation (PS Version 3.0.43) software. At a given two-sided significance level of α = 5%, a standardized effect of 1 with a power of 1 − β = 80% should be demonstrated by the test. For a solid basis of measurement data, a study population of at least 20 per group (PIEZO: 40, SAW and BUR Groups: 20) was considered necessary.
6
RESULTS The study included 80 patients (40 females and 40 males), aged between 15 and 34 years (20.6 ±4.7) with complete skeletal development, who were diagnosed with MTD (> 5 mm) as per the posteroanterior radiographs. The edema levels, VAS scores for postoperative pain and patient satisfaction assessment, the total duration of osteotomy and correlation between the variables were analyzed statistically. (Tables 1-3) Edema on the 2nd Day The quantitative and statistical comparisons between pre-operative MFNS and postoperative MFES on the 2nd day are shown in Table 3 and Figure 3. The differences in MFES between the PIEZO and BUR groups or the BUR and SAW groups were statistically significant while it was nonsignificant between the PIEZO and SAW groups. Though quantitatively, the least edema appeared to be in the PIEZO group, the difference between the PIEZO and SAW groups was mild and statistically nonsignificant while the edema was the highest in the BUR group. In the AL measurement, the PIEZO group had a significantly lower score as compared to the BUR group (p=0.003). The difference in TS measurements between the PIEZO and BUR groups was also statistically significant (p=0.011). Edema on the 7th Day Quantitative and statistical intragroup analyses of the decreases in the MFES in all groups between pre-op MFNS and 7th day MFES are shown in Table 3. The difference in MFES was statistically significant between the PIEZO and BUR (p<0.001) or PIEZO and SAW (p=0.015) groups, while that between the BUR and SAW groups was nonsignificant (p=0.315). The difference between the PIEZO and BUR groups was statistically significant in all measurements except CL (p=0.227), while the differences between the BUR and SAW groups were statistically nonsignificant. The only statistically significant difference between the PIEZO and SAW groups was the AL measurement (p=0.007). Similar to the 2nd day, the measurements were also found to be quantitatively lower in the PIEZO group (%2,1) on the 7th day (Figure 3).
7
Edema on the 10th Day The total edema measured on the 10th postoperative day in MFES and statistical analysis among the groups are shown in Table 3. Although considering the MFES, the least edema was found in the PIEZO group on the 10th day; only the difference in MFES between the PIEZO and BUR groups was statistically significant (P<0.001). On the 10th day, the difference between MFNS and MFES was only 0.6% for the PIEZO group, though it was still statistically significant (p=0.001). The maximum decrease in overall edema was seen in BUR group (6.8%) between the 2nd and 10th days; however, the maximal facial edema was still in the BUR group (2.1%) (Figure 3) Edema on the 14th Day In all four facial measurements, the differences among groups and the differences between the PIEZO and BUR or BUR and SAW groups were statistically significant, while those between the PIEZO and SAW groups were not. Regarding the difference between MFNS and MFES on the 14th day, the least edema was observed in the PIEZO group (%0,1) and the difference was statistically nonsignificant in this group (p=0.577), which indicates that the level of edema in the PIEZO group was almost near to that of the MFNS. The edema in the SAW (%0,7) and BUR (%1,0) group was still persistent and statistically significant (p=0.001) (Figure 3). Considering the MFES, the differences between the PIEZO and BUR groups (p<0.001), or PIEZO and SAW groups (p=0.005) were statistically significant while those between BUR and SAW group were not (p=0.099) (Table 3). The decrease in overall edema between the 10th and 14th days was statistically nonsignificant in the PIEZO group (p=0.199) while it was significant in the SAW and BUR groups (p<0.001). VAS Scores The mean VAS score for pain in the PIEZO group was lower than that in the other groups (p<0.05). Similarly, the comparisons between the PIEZO and BUR or the PIEZO and SAW groups were statistically significant. Postoperatively, the patients experienced significantly lesser pain by piezosurgery compared to the other two methods (p<0.05). There was no statistically significant difference between the SAW and BUR groups (p=0.855) (Table 1). Patient satisfaction was evaluated for perceived vibration, noise, operating time, early postoperative pain, and swelling related to the procedure. The patient satisfaction obtained 8
by piezosurgery was significantly higher (p<0.01). There was no statistically significant difference between the SAW and BUR groups (p=0.741). (Table 1) Operating time The average time difference between the groups was found to be statistically significant. In the PIEZO group, osteotomy took a significantly longer time than the other methods (p<0.05). On the other hand, there was no statistically significant difference between the SAW and BUR groups (p=0.620). Correlation between MFES with secondary variables Spearman’s correlation test was performed to examine if MFES and secondary study variables (VAS score for pain, VAS score for patient satisfaction, and operating time) were correlated. Pertaining to the results, edema was not found to be correlated with any of the mentioned variables (Table 2). Yet, the VAS score for pain and patient satisfaction were observed to be strongly correlated (p<0,001).
9
DISCUSSION This study was performed with the purpose of comparing the edema, postoperative pain, patient satisfaction, and operating time in the SARPE technique, as performed with piezosurgery or reciprocal microsaw and conventional burs with osteotomes. The investigators hypothesized that there would be no difference in any of the outcomes between the groups. However, the results revealed that edema was lesser in the PIEZO group and resolved in a shorter duration. The patients experienced significantly less postoperative pain during piezosurgery and the patient satisfaction obtained by piezosurgery was significantly higher in comparison to the other two methods. However, osteotomy took a significantly longer time in the PIEZO group. Any surgical trauma stimulates a cellular response and begins the process of digestion to eliminate the necrotic tissues. Excessive tissue damage and necrotic cells at the surgical site result in an intense inflammatory response, ensuring a high level of edema. Piezosurgery offers some crucial advantages; low bone injury resulting from the absence of coagulation necrosis and micrometric cutting ability are two significant characteristics of piezosurgery. It also offers better hemostasis, which reduces the risk of edema altogether.5, 8–10 The authors investigated if the thickness of the maxillary osteotomy line could be the primary factor determining the level of postoperative facial edema. A comparison of the average edema level among groups in the study indicated that this assertion is controversial since the level of facial edema in the SAW group was more than that in the PIEZO group, considering that reciprocal microsaw (0.35 mm) is thinner than the piezosurgery inserts (0.75 mm). Besides, the BUR group was still the one with considerable facial edema suggesting that the osteotomy thickness is critical but it is not the only factor. Although the burs were the thickest (1 mm) in the BUR group, the comparison of the edema level between the SAW and BUR groups was not statistically significant at the second postoperative day. The results of the present study may provoke new research to identify whether the hemostatic features of piezosurgery, low tissue damage resulting from the absence of coagulation necrosis and better survival of the bone cells, which may be the significant factors for low edema, might really have an effect on the reduced edema. The results of this study suggest that, although not definitive, the features of piezosurgery mentioned above, might be responsible for the low levels of edema after subtotal LeFort I 10
osteotomy in the PIEZO group in comparison to the BUR and SAW groups. Preti et al.11 found that neo-osteogenesis was consistently more active in bony samples from implant sites, which had been prepared via piezosurgery rather than by conventional burs. Earlier research has also shown that there was an early increase in bone morphogenetic protein–4 (BMP–4) and transforming growth factor–2 (TGF–2) proteins, and that fewer pro-inflammatory cytokines were released in bone with piezosurgery. In this study, the fastest resolution of edema occurred in the PIEZO group. Along the entire post-operative course, the PIEZO group exhibited the minimum edema as compared to the other groups. In terms of the MFES on day 14, edema almost disappeared in the PIEZO group while it decreased slowly in the BUR and SAW groups. This observation may suggest that piezosurgery is more effective in the early phase of bone healing by inducing an early increase in BMP and TGF, controlling the inflammatory reactions in a better manner, stimulating the remodeling of the bone and by inducing a faster edema resolution, postoperatively. Further histological animal studies with a similar design may clarify these assumptions. Spinelli et al.12 reported that piezosurgery gives better results in terms of intraoperative blood loss, postoperative edema, hematoma, and nerve damage as compared to the conventional techniques in orthognathic surgical procedures, thus helping the surgeon achieve patient satisfaction. Landes et al.13 in anterior iliac bone graft harvesting procedure and Robiony et al.14 in rhinoplasty surgeries also obtained better results with piezosurgery as compared to the conventional methods. In a systematic review and meta-analysis, AlMoraissi et al.15 concluded that piezosurgery significantly reduces the occurrence of postoperative pain and edema, in 3rd molar surgeries. The results of the present study concur with the other studies comparing conventional techniques with piezosurgery in terms of edema and pain. The patients experienced significantly lesser pain in piezosurgery. The authors also noted that, in terms of the MFES, edema was lower all along the post-operative course and returned to normal levels faster with piezosurgery. Post-operative edema is the most common complaint following facial surgeries. Although the patients do not feel much discomfort or pain associated with their facial appearance, the postoperative edema is socially disturbing and frightening.16 The relationship between preoperative patient expectations and postoperative patient satisfaction in orthognathic surgery has been evaluated in some studies.17, 18 Kiyak et al.17 reported that patients with 11
less pain and swelling than expected were the most satisfied ones or vice versa. Rana et al.19 compared piezosurgery and SAW with osteotomes in SARPE patients and reported that the swelling was not intense and disappeared quickly in both the groups. They concluded that postoperative pain did not make a statistically significant difference between the two groups; however, patient satisfaction was statistically higher in the piezosurgery group. Considering lesser pain, even though contrary to Rana et al.19, and edema after SARPE with piezosurgery, the results of this study support the findings of Kiyak et al.17 and Rana et al.19 The authors concluded that neither pain nor patient satisfaction was correlated with edema; even though pain and patient satisfaction were strongly correlated with each other. These results partially support the findings of Kiyak et al.17, suggesting that the most satisfied patients were the ones with lesser postoperative pain, regardless of the level of edema. Robiony et al.20 reported that patient comfort increases with piezosurgery in SARPE under local anesthesia as there is no need for osteotome and hammer during this procedure. Laino et al.21 indicated that SARPE can be safely performed under local anesthesia and that the intra- and post-operative discomfort levels of the procedure are similar to other procedures, typically performed under local anesthesia. This study aimed to compare the use of conventional methods and piezosurgery in terms of intra-operative patient satisfaction, which makes the local anesthesia a perfect choice. No patient complained of pain during the surgery, though, all patients in the BUR and SAW groups reported that the use of pterygoid osteotomes and hammers was psychologically disturbing. 19 Despite the lesser vibrations and lower levels of disturbing sounds, the absence of hammering should be considered as one of the most important factors increasing patient satisfaction. This may explain the statistical difference obtained among the groups in this study. Many authors have stated that the most significant disadvantage of piezosurgery is the time factor and osteotomies in orthognathic surgeries take a longer time than conventional osteotomies due to the relatively low cutting efficiency of piezosurgery. However, studies have also emphasized that piezosurgery is a better alternative compared to the conventional methods when all other advantages, especially its low risk of damage to the neighboring soft tissues, are considered.10, 19, 22–25 In the present study, osteotomies with piezosurgery took 49% more time as compared to the BUR group and 40% more time than that in the SAW groups. However, a longer operating time was expected since the pterygomaxillary 12
disjunction was performed with angled piezosurgery tips, which prolongs the duration. These differences were statistically significant; although, the clinical importance of this difference is controversial. Rotary tools convert electrical or air pressure energy into a mechanical cutting function by use of sharp burs or saws. These devices produce a significant amount of heat and may lead to marginal osteonecrosis, thus altering or delaying the healing response. Low rotation speed reduces not only the amount of heat generated but also the cutting efficiency. The presence of macro vibrations makes the instrument prone to slipping, thus making it less manageable and difficult to be used for cutting of different anatomical regions. They have an inevitable risk of damaging the surrounding soft tissues such as nerves, veins, and mucosa.5, 8, 26
The safety of the use of a reciprocating SAW or similar techniques at specific sites with a high risk of soft tissue damage such as the pterygomaxillary junctions is controversial. Some authors advocate that even the use of curved pterygoid osteotomies should be abandoned as it may damage the content of pterygopalatine fossa, resulting in high pterygoid plate fractures or fractures extending to the skull base and orbit.27, 28 In contrast, Ueki et al.29 and Robiony et al.20 reported that ultrasonic devices advantageously provide a safe way of relieving pterygomaxillary junction without damaging the surrounding soft tissues. The authors of this study experienced that the selective cutting feature of piezosurgery helps the surgeon preserve the soft tissues in critical areas, and the device can be handled conveniently thereby allowing a smooth relief of the pterygomaxillary junction with exceptionally controlled bleeding, possibly due to its cavitation effect. Mild to moderate bleeding was observed in ten patients (25%) after releasing the pterygomaxillary junction by curved osteotomes; nevertheless, no bleeding occurred when it was released by piezosurgery. This benefit can be attributed to the protection of the intense vascular network of the pterygomaxillary region by piezosurgery vibrations and the effect of cavitation, causing coagulation in small vessels. The present study supports other studies reporting the fact that relieving the pterygomaxillary junction with piezosurgery is highly safe and predictable.
13
There is no standard procedure to quantify the level of edema. Although various methods (calipers, facial arches, photographic or stereophotographic methods, computed tomography, magnetic resonance imaging, etc.) have been proposed to measure the threedimensional facial swelling or edema, none of them is accurate.30 In this study, a modified flexible ruler method, proposed by Neupert et al.6 was utilized. The choice of the ruler method to quantify the level of edema could be attributed as a weakness, as this method does not precisely determine the volume of soft facial tissues like that in computed tomography or magnetic resonance imaging. However, it is non-invasive, simple, effective, and time-saving. This still offers some quantitative estimates suitable for comparative analysis of changes in the soft tissue contour. Unfortunately, the effect of the method in relieving pterygomaxillary junction could not be properly evaluated on facial edema using the ruler method, which was another weakness of this study. The authors could only suggest that separation of the pterygomaxillary junction with piezosurgery possibly produces less swelling in the early post-operative phase due to the effect of cavitation causing coagulation. Further studies with a similar design that would use CT or MRI to quantify the effect of the method to relieve pterygoid junction on facial edema might unveil the effect of this confounding variable, which would enable the surgeons to take it into account correctly.
14
CONCLUSIONS The SARPE procedure can comfortably be performed under local anesthesia, and the edema level after osteotomies is statistically lower in piezosurgery and microsaw groups as compared to that in conventional burs. Further, edema resolves faster with piezosurgery than that with conventional burs and microsaw. In piezosurgery, the level of pain is lower. It was observed that piezosurgery increases the satisfaction and cooperation of patients by preventing and inducing lesser psychological trauma, caused by the use of osteotome and hammer. As a disadvantage, osteotomies performed by piezosurgery took 50% longer time. Further, no significant differences were found between the SAW and the BUR groups in terms of operating time, VAS, and edema level; however, healing took more time in the BUR and SAW groups due to persistent edema. The present study determined that piezosurgery allows the release of the pterygomaxillary junction with excellent bleeding control in comparison to the curved pterygoid osteotomes.
15
REFERENCES 1. Anttila A, Finne K, Keski-Nisula K, Somppi M, Panula K, Peltomaki T: Feasibility and longterm stability of surgically assisted rapid maxillary expansion with lateral osteotomy. Eur J Orthod 26:391, 2004 2. Koudstaal MJ, Poort LJ, van der Wal KG, Wolvius EB, Prahl-Andersen B, Schulten AJ: Surgically assisted rapid maxillary expansion (SARME): a review of the literature. Int J Oral Maxillofac Surg 34:709, 2005 3. Vercellotti T, Nevins ML, Kim DM, Nevins M, Wada K, Schenk RK, Fiorellini JP: Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent 25:543, 2005 4. Gruber RM, Kramer FJ, Merten HA, Schliephake H: Ultrasonic surgery--an alternative way in orthognathic surgery of the mandible. A pilot study. Int J Oral Maxillofac Surg 34:590, 2005 5. Schaller BJ, Gruber R, Merten HA, Kruschat T, Schliephake H, Buchfelder M, Ludwig HC: Piezoelectric bone surgery: a revolutionary technique for minimally invasive surgery in cranial base and spinal surgery? Technical note. Neurosurgery 57:E410; discussion E410, 2005 6. Neupert EA, third, Lee JW, Philput CB, Gordon JR: Evaluation of dexamethasone for reduction of postsurgical sequelae of third molar removal. J Oral Maxillofac Surg 50:1177, 1992 7. van der Westhuijzen AJ, Becker PJ, Morkel J, Roelse JA: A randomized observer blind comparison of bilateral facial ice pack therapy with no ice therapy following third molar surgery. Int J Oral Maxillofac Surg 34:281, 2005 8. Vercellotti T, Pollack AS: A new bone surgery device: sinus grafting and periodontal surgery. Compend Contin Educ Dent 27:319, 2006 9. Leclercq P, Zenati C, Amr S, Dohan DM: Ultrasonic bone cut part 1: State-of-the-art technologies and common applications. J Oral Maxillofac Surg 66:177, 2008 10. Bertossi D, Lucchese A, Albanese M, Turra M, Faccioni F, Nocini P, Rodriguez YBR: Piezosurgery versus conventional osteotomy in orthognathic surgery: a paradigm shift in treatment. J Craniofac Surg 24:1763, 2013
16
11. Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G: Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol 78:716, 2007 12. Spinelli G, Lazzeri D, Conti M, Agostini T, Mannelli G: Comparison of piezosurgery and traditional saw in bimaxillary orthognathic surgery. J Craniomaxillofac Surg 42:1211, 2014 13. Landes CA, Stubinger S, Laudemann K, Rieger J, Sader R: Bone harvesting at the anterior iliac crest using piezoosteotomy versus conventional open harvesting: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 105:e19, 2008 14. Robiony M, Toro C, Costa F, Sembronio S, Polini F, Politi M: Piezosurgery: a new method for osteotomies in rhinoplasty. J Craniofac Surg 18:1098, 2007 15. Al-Moraissi EA, Elmansi YA, Al-Sharaee YA, Alrmali AE, Alkhutari AS: Does the piezoelectric surgical technique produce fewer postoperative sequelae after lower third molar surgery than conventional rotary instruments? A systematic review and meta analysis. Int J Oral Maxillofac Surg 45:383, 2016 16. Yucel OT: Which type of osteotomy for edema and ecchymosis: external or internal? Ann Plast Surg 55:587, 2005 17. Kiyak HA, Vitaliano PP, Crinean J: Patients' expectations as predictors of orthognathic surgery outcomes. Health Psychol 7:251, 1988 18. Neal CE, Kiyak HA: Patient perceptions of pain, paresthesia, and swelling after orthognathic surgery. Int J Adult Orthodon Orthognath Surg 6:169, 1991 19. Rana M, Gellrich NC, Rana M, Piffko J, Kater W: Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy – a randomized prospective trial. Trials 14:49, 2013 20. Robiony M, Polini F, Costa F, Zerman N, Politi M: Ultrasonic bone cutting for surgically assisted rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg 36:267, 2007 21. Laino L, Troiano G, Dioguardi M, Perillo L, Laino G, Lo Muzio L, Cicciu M: Patient Discomfort During and After Surgically Assisted Rapid Maxillary Expansion Under Local Anaesthesia. J Craniofac Surg 27:772, 2016
17
22. Olate S, Pozzer L, Unibazo A, Huentequeo-Molina C, Martinez F, de Moraes M: LeFort I segmented osteotomy experience with piezosurgery in orthognathic surgery. Int J Clin Exp Med 7:2092, 2014 23. Akbar Z, Saleem H, Ahmed W: Critical Analysis of Piezoelectric Surgery with Oscillating Saw in Bimaxillary Orthognathic Surgery. J Coll Physicians Surg Pak 27:348, 2017 24. Mohlhenrich SC, Ayoub N, Fritz U, Prescher A, Holzle F, Modabber A: Evaluation of ultrasonic and conventional surgical techniques for genioplasty combined with two different osteosynthesis plates: a cadaveric study. Clin Oral Investig 21:2437, 2017 25. Bertossi D, Albanese M, Nocini R, Mortellaro C, Kumar N, Nocini PF: Osteotomy in Genioplasty by Piezosurgery. J Craniofac Surg, 2018 26. Kerawala CJ, Martin IC, Allan W, Williams ED: The effects of operator technique and bur design on temperature during osseous preparation for osteosynthesis self-tapping screws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88:145, 1999 27. Robinson PP, Hendy CW: Pterygoid plate fractures caused by the Le Fort I osteotomy. Br J Oral Maxillofac Surg 24:198, 1986 28.
Lanigan DT, Guest P: Alternative approaches to pterygomaxillary separation. Int J Oral
Maxillofac Surg 22:131, 1993 29. Ueki K, Nakagawa K, Marukawa K, Yamamoto E: Le Fort I osteotomy using an ultrasonic bone curette to fracture the pterygoid plates. J Craniomaxillofac Surg 32:381, 2004 30. Weber CR, Griffin JM: Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg 52:35, 1994
18
FIGURE LEGENDS Figure 1. Marked anatomical points to perform facial norms and postoperative facial edema measurements. White line: Commissura labiorum–Tragus (CT), Red line: Angulus mandibula–Lateral canthus (AL), Blue line: Commissura labiorum–Lateral canthus (CL) Black line: Tragus–Sulcus nasolabialis (TS). Figure 2. Separation of pterygomaxillary junction by piezosurgery Figure 3. Changes in the percentage of the edema levels on post-operative 2nd, 7th, 10th, and 14th days (Paired t-test.)
19
TABLES (PIEZO-BUR-SAW) Mean
SD
(PIEZO-
(PIEZO-
(BUR-
BUR)
SAW)
SAW)
P
P
P
P
<0.001
0.005
0.001
0.855
VAS SCORES FOR PAIN (MM) PIEZO
2.3
0.3
BUR
3.6
0.4
SAW
3.9
0.6
VAS SCORES FOR POST OPERATIVE PATIENT SATISFACTION (MM) PIEZO
8.3
0.3
BUR
5.5
0.5
SAW
5.1
0.9
<0.01
0.05
0.01
0.741
0.0001
0.0001
0.0001
0.620
DURATION OF OPERATION (MIN) PIEZO
16.10
±3.30
BUR
11.05
±2.09
SAW
11.20
±2.14
Table 1. The quantitative and statistical analysis of VAS Scores (in millimeters) of the patients for pain, post-operative satisfaction, and duration of operation (Minutes) among the groups. (SD: Standard deviation)
20
MEAN FACIAL EDEMA SCORES Day 2
Day 7
Day 10
Day 14
R
-,162
-,137
-,190
-.238
P
,150
,225
,091
,034
VAS SCORE FOR POST OPERATIVE
R
,117
,087
,149
,188
PATIENT SATISFACTION (MM)
P
,302
,445
,186
,095
DURATION OF OPERATION (MIN)
R
-,067
-,072
-,032
-,020
P
,554
,526
,779
,859
VAS SCORE FOR PAIN (MM)
Table 2. Mean facial edema scores versus secondary study variables. (r: Pearson’s correlation coefficient)
21
Pre-op vs. Day 2
Pre-op vs. Day 7
Pre-op vs. Day 10
Pre-op vs. Day 14
MEAN FACIAL
PIEZO-
PIEZO-
PIEZO-
BUR-
EDEMA SCORES
SAW-
BUR
SAW
SAW
(MFES)
BUR p
p
p
p
MEAN
SD
(mm)
(mm)
PIEZO
0.53
0.34
0.000
0.000
0.373
0.002
SAW
0.61
0.30
*
**
**
**
BUR
0.94
0.33
PIEZO
0.21
0.25
0.001
0.000
0.015
0.315
SAW
0.35
0.20
***
****
****
****
BUR
0.42
0.21
PIEZO
0.06
0.19
0.000
0.000
0.063
0.064
SAW
0.15
0.13
***
****
****
****
BUR
0.20
0.10
PIEZO
0,02
0.13
0.000
0.000
0.005
0.099
SAW
0.06
0.07
***
****
****
****
BUR
0.10
0.07
* ANOVA, ** Independent t-test, ***Kruskal Wallis test b, **** Mann Whitney U test Table 3. The quantitative and statistical analysis of differences in mean facial edema score (MFES) among the groups in the post-operative 2nd, 7th, 10th, and 14th days. (SD: Standard deviation)
22