Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05310019
Study type Interventional
Source University of Nove de Julho
Contact Daniela A Biasotto-Gonzalez
Phone +5511999063166
Email biasottogonzalez@gmail.com
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date July 2024

See also
  Status Clinical Trial Phase
Completed NCT06003205 - Contributing Factors to Local Bioimpedance Spectroscopy N/A
Completed NCT02055872 - Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial Phase 3
Completed NCT01172522 - Topical Treatment of Under Eye Dark Circles and Swelling Phase 2
Completed NCT00602615 - Bioequivalency Study of Torsemide Tablets Under Fed Conditions N/A
Completed NCT00602303 - Bioequivalency Study of Torsemide Tablets Under Fasting Conditions N/A
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Completed NCT04595448 - Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
Recruiting NCT06014203 - Examination of Edema After Arthroscopic Shoulder Surgery
Completed NCT06010394 - Control of Edema in the Knee in Patients With Knee Osteoarthritis N/A
Recruiting NCT03442166 - Effectiveness of Light-emitting Diode (LED) Photobiomodulation in the Extraction of Retained Lower Third Molars Phase 2
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Withdrawn NCT03603990 - Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema N/A
Recruiting NCT04927234 - Foot and Ankle Post-operative Oedema Management Using Geko™ N/A
Active, not recruiting NCT02876107 - Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer Phase 2
Recruiting NCT03704857 - Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life N/A
Recruiting NCT04606030 - LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) N/A
Completed NCT00732719 - Compression Device Safety Study on Edema Phase 2
Not yet recruiting NCT05534308 - Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping N/A
Completed NCT04205253 - Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
Terminated NCT03296085 - Bedside Evaluation of Edema