Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

Not Applicable

Completed

• Conditions: Edema; Paresthesia

• Registration Number: NCT05310019
• Lead Sponsor: University of Nove de Julho

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-04
• Primary Completion: 2024-12-10
• Status Verified: 2025-02
• Study Completion: 2025-02-25
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Adults undergoing bimaxillary orthognathic surgery and mentoplasty;
• Aged between 18 and 50 years;
• Both of genders,
• Having at least 24 teeth, with Class II or III skeletal malocclusion;
• Diagnosed by cephalometric radiographs, who have performed the surgery in the period from 1 to 45 days before the beginning of physiotherapy;
• Be available to perform the proposed postoperative treatment at the Clinic School of Physiotherapy of the Estácio do Ceará University Center for six weeks;
• Agree to participate in the research;
• Sign the term of free and clear clarification.

Exclusion Criteria

• Individuals with cleft lip or palate, previous orthopedic and/or rheumatologic diseases that may have repercussions on the face such as facial fractures, facial palsy, systemic lupus erythematosus, neurological alteration due to injury or compression of the facial or trigeminal nerve;
• Patients with chronic lymphedema, individuals treated or undergoing cancer treatment, syndromic, with local vascular changes or who have undergone previous surgeries on the face such as bichectomy, TMJ surgery, with the exception of tooth extraction without associated nervous impairment, who performed other surgical procedures combined with orthognathic;
• Patients who use botulinum toxin for the treatment of temporomandibular dysfunction and esthetics;
• Patients who presented postoperative complications such as infectious processes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
sensitivity assessment	the sensitivity assessment at 6 months	Using the Semmes-Weinstein monofilament test

Secondary Outcome Measures

Name	Time	Method
measure functionality	measure Functionality at 6 months	The functionality will be measured with Chewing Quality Assessment Questionnaire
measure range of motion	The range of motion at at 6 months	range of motion (measure with digital calipers)
measure edema	the edema assessment at 6 months	The edema will be measured with the aid of a measuring tape.

Trial Locations

Locations (1)

Clinic School of the University Center Estácio do Ceará; 🇧🇷 Fortaleza, Ceará, Brazil