Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

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.

Conditions

• Paresthesia
• Edema

Interventions

OTHER

Physiotherapy and Electroacupuncture

TThe physiotherapy treatment (50min): warm compress with facial thermal blanket, respiratory muscle mobility training and cervical muscle relaxation, facial lymphatic drainage, start of myolymphokinetic exercises for the orbicularis, zygomatic major and minor muscles, upper lip lifter and nose wing, buccinator and platysma, release of intraoral adhesions, vacuum therapy at 60 mmHg, active exercises free of mandibular movements, maintenance of mandibular opening with wooden tongue depressors. The electroacupuncture treatment lasting another 30 min. Electroacupuncture treatment lasting another 30min. The repetition time of 1 sec; (F1-10 Hz, F2= 45 Hz; 10 mA). Facial acupuncture needles are disposable with 0.20 mm gauge and 10 mm length. Each needle will be inserted at the indicated points, totaling 10 needles and electrodes will be connected to each one. Electrical stimulation will be performed on the face points: E4, Jiachengjiang (extra point), E5, E6, bilaterally and point CV-24.

OTHER

Physiotherapy

The physiotherapy treatment protocol will be divided into 6 meetings: warm compress with facial thermal blanket (5min), respiratory muscle mobility training and cervical muscle relaxation (5min) facial lymphatic drainage (10min), start of myolymphokinetic exercises for the orbicularis oris, zygomatic major and minor muscles, upper lip lifter and nose wing, buccinator and platysma (5 min), release of intraoral adhesions (5min) vacuum therapy at 60 mmHg (5min), active exercises free of mandibular movements (5 min), maintenance of mandibular opening with wooden tongue depressors (10min).

Sponsors & Collaborators

• Universidade Federal do Ceará

  collaborator UNKNOWN

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Itana L Spinato · Universidade Federal do Ceará

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2024-12-10

Completion

2025-02-25

Countries

• Brazil

Study Locations