Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
Introduction: Among the major oral and maxillofacial surgeries called reconstructive, theone that has become popular in recent years, especially after the mandatory coverage ofcosts by health plans, was orthognathic surgery, so called because it is a combinedprocedure between orthodontics and oral and maxillofacial surgery, aiming at thecorrection of the masticatory system with the objective of reducing the discrepanciesrelated to the jaws and, thus, establishing harmony between the face and the skull.Lesions of the inferior alveolar nerve (INA) are frequent due to its anatomical location,passing through the sagittal osteotomy of the mandibular ramus, where manipulation of themandibular ramus or the structures that surround the nerve occurs during the operation.Goals. To evaluate the effect of electroacupuncture on paresthesia and myofunctionalchanges in patients undergoing bimaxillary orthognathic surgery and mentoplasty.Methodology: this is a controlled, randomized, blinded clinical trial. The sample wasdefined from a pilot study involving ten individuals, considering as an outcome thesensitivity obtained under the same experimental conditions used in this study. A two‐wayANOVA with repeated measures considering two factors, group (treatment and control) andirradiation (pre‐, post‐6 treatment session and post‐3 plot) was used to calculate thesquared value of the ETA (0.033). The estimated number was 50 individuals per group. Forsample calculation, α=0.05 (5% chance of type I error) and 1‐β= 0.80 (% of samplingpower) were considered. The sample will be increased by 20% to compensate for possibledropouts, resulting in 62 individuals in each group (overall sample = 124 participants).Therefore, 124 young adults, aged between 18 and 50 years, both sexes, with at least 24teeth, with Class II or III skeletal malocclusion, diagnosed by cephalometricradiographs, who underwent orthognathic surgery in the period from 1 to 30 days beforethe start of physical therapy, be available to perform the proposed postoperativetreatment for six weeks. Participants will be equally and randomly distributed into twoexperimental groups: GF (Physiotherapy Group), GFE (Physiotherapy plus ElectroacupunctureGroup). The variables to be studied will be: socioepidemiological data; sensitivityassessment by the Semmes‐Weinstein monofilament test; Edema assessment by the MD AndersonCancer Center Head and Neck Lymphedema protocol, validated in Portuguese; assessment ofmandibular movements using a Western‐DC digital caliper; Assessment of masticatoryfunction using the Chewing Quality Assessment Questionnaire. Data will be analyzeddescriptively and organized into tables. Subsequently, the normality of continuousvariables will be tested by the Kolmogorov‐Smirnov test. As the variables are normallydistributed, we will use parametric tests such as the paired t test, independent t test,ANOVA and Pearson's correlation. Nonparametric tests such as Wilcoxon paired signed ranktest, Mann‐Whitney U test, Kruskal Wallis test, Spearman correlation test will be used incase of non‐normality of continuous variables. The significance level will be adjusted to5% in all analyses.
Epistemonikos ID: 250cc9f66fec58e1b46e05fec94aa48b44dac17a
First added on: May 13, 2024