- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05310019
Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty
March 13, 2024 updated by: Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniela A Biasotto-Gonzalez
- Phone Number: +5511999063166
- Email: biasottogonzalez@gmail.com
Study Locations
-
-
Ceará
-
Fortaleza, Ceará, Brazil, 60125-160
- Recruiting
- Clinic School of the University Center Estácio do Ceará
-
Contact:
- Itana Lisane Spinsto, Master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiotherapy plus Electroacupuncture Group
The 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.
|
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.
|
Active Comparator: Physiotherapy Group
The physiotherapy protocol will be the same as the active group.
Protocol: warm compress with facial thermal blanket (5 min), respiratory muscle mobility training and cervical muscle relaxation (5 min) facial lymphatic drainage (10 min), start of myolyphokinetic exercises for the orbicularis oris, zygomatic major and minor, levator labii superioris and nasal ala, buccinator and platysma (5 min), release of intraoral adhesions (5 min) vacuum therapy at 60 mmHg (5 min), active exercises free of mandibular movements of right and left laterality, protrusion and mandibular opening (5 min), maintenance of mandibular opening with wooden tongue depressors (10 min).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity assessment
Time Frame: the sensitivity assessment at 6 months
|
Using the Semmes-Weinstein monofilament test
|
the sensitivity assessment at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure range of motion
Time Frame: The range of motion at at 6 months
|
range of motion (measure with digital calipers)
|
The range of motion at at 6 months
|
measure edema
Time Frame: the edema assessment at 6 months
|
The edema will be measured with the aid of a measuring tape.
|
the edema assessment at 6 months
|
measure functionality
Time Frame: measure Functionality at 6 months
|
The functionality will be measured with Chewing Quality Assessment Questionnaire
|
measure Functionality at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Itana L Spinato, Universidade Federal Do Ceara
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
March 2, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 4, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30725720.7.0000.5054.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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