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Effect of Electroacupuncture on Paresthesias and Functional Changes in Patients Submitted to Bimaxillary Orthognathic Surgery and Mentoplasty
Goals. To evaluate the effect of electroacupuncture on paresthesia and myofunctional changes in patients undergoing bimaxillary orthognathic surgery and mentoplasty. Methodology: this is a controlled, randomized, blinded clinical trial. The sample will consist of 62 individuals in each group (general sample = 124 participants). Therefore, 124 young adults, aged between 18 and 50 years, both sexes, with at least 24 teeth, with Class II or III skeletal malocclusion, diagnosed by cephalometric radiographs, who underwent orthognathic surgery in the period from 1 to 30 days before the start of physical therapy, be available to perform the proposed postoperative treatment for six weeks. Participants will be equally and randomly distributed into two experimental groups: GF (Physiotherapy Group), GFE (Physiotherapy plus Electroacupuncture Group). The variables to be studied will be: socioepidemiological data; sensitivity assessment by the Semmes-Weinstein monofilament test; Edema assessment by the MD Anderson Cancer Center Head and Neck Lymphedema protocol, validated in Portuguese; assessment of mandibular movements using a Western-DC digital caliper; Assessment of masticatory function using the Chewing Quality Assessment Questionnaire. Data will be analyzed descriptively and organized into tables. Subsequently, the normality of continuous variables will be tested by the Kolmogorov-Smirnov test. As the variables are normally distributed, 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 rank test, Mann-Whitney U test, Kruskal Wallis test, Spearman correlation test will be used in case of non-normality of continuous variables. The significance level will be adjusted to 5% in all analyses.
Introduction: Among the major oral and maxillofacial surgeries called reconstructive, the one that has become popular in recent years, especially after the mandatory coverage of costs by health plans, was orthognathic surgery, so called because it is a combined procedure between orthodontics and oral and maxillofacial surgery, aiming at the correction of the masticatory system with the objective of reducing the discrepancies related 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 the mandibular ramus or the structures that surround the nerve occurs during the operation. Goals. To evaluate the effect of electroacupuncture on paresthesia and myofunctional changes in patients undergoing bimaxillary orthognathic surgery and mentoplasty. Methodology: this is a controlled, randomized, blinded clinical trial. The sample was defined from a pilot study involving ten individuals, considering as an outcome the sensitivity obtained under the same experimental conditions used in this study. A two-way ANOVA with repeated measures considering two factors, group (treatment and control) and irradiation (pre-, post-6 treatment session and post-3 plot) was used to calculate the squared value of the ETA (0.033). The estimated number was 50 individuals per group. For sample calculation, α=0.05 (5% chance of type I error) and 1-β= 0.80 (% of sampling power) were considered. The sample will be increased by 20% to compensate for possible dropouts, 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 24 teeth, with Class II or III skeletal malocclusion, diagnosed by cephalometric radiographs, who underwent orthognathic surgery in the period from 1 to 30 days before the start of physical therapy, be available to perform the proposed postoperative treatment for six weeks. Participants will be equally and randomly distributed into two experimental groups: GF (Physiotherapy Group), GFE (Physiotherapy plus Electroacupuncture Group). The variables to be studied will be: socioepidemiological data; sensitivity assessment by the Semmes-Weinstein monofilament test; Edema assessment by the MD Anderson Cancer Center Head and Neck Lymphedema protocol, validated in Portuguese; assessment of mandibular movements using a Western-DC digital caliper; Assessment of masticatory function using the Chewing Quality Assessment Questionnaire. Data will be analyzed descriptively and organized into tables. Subsequently, the normality of continuous variables will be tested by the Kolmogorov-Smirnov test. As the variables are normally distributed, 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 rank test, Mann-Whitney U test, Kruskal Wallis test, Spearman correlation test will be used in case of non-normality of continuous variables. The significance level will be adjusted to 5% in all analyses.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Clinic School of the University Center Estácio do Ceará
Fortaleza, Ceará, Brazil
Start Date
September 1, 2020
Primary Completion Date
December 10, 2024
Completion Date
February 25, 2025
Last Updated
February 28, 2025
118
ACTUAL participants
Physiotherapy and Electroacupuncture
OTHER
Physiotherapy
OTHER
Lead Sponsor
University of Nove de Julho
Collaborators
NCT07298447
NCT07449936
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07434908