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Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

Primary Purpose

Paresthesia, Edema

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physiotherapy and Electroacupuncture
Physiotherapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paresthesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic School of the University Center Estácio do CearáRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiotherapy plus Electroacupuncture Group

Physiotherapy Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

sensitivity assessment
Using the Semmes-Weinstein monofilament test

Secondary Outcome Measures

measure range of motion
range of motion (measure with digital calipers)
measure edema
The edema will be measured with the aid of a measuring tape.
measure functionality
The functionality will be measured with Chewing Quality Assessment Questionnaire

Full Information

First Posted
March 2, 2022
Last Updated
February 7, 2023
Sponsor
University of Nove de Julho
Collaborators
Universidade Federal do Ceará
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1. Study Identification

Unique Protocol Identification Number
NCT05310019
Brief Title
Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty
Official Title
Effect of Electroacupuncture on Paresthesias and Functional Changes in Patients Submitted to Bimaxillary Orthognathic Surgery and Mentoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Universidade Federal do Ceará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paresthesia, Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy plus Electroacupuncture Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physiotherapy and Electroacupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
sensitivity assessment
Description
Using the Semmes-Weinstein monofilament test
Time Frame
the sensitivity assessment at 6 months
Secondary Outcome Measure Information:
Title
measure range of motion
Description
range of motion (measure with digital calipers)
Time Frame
The range of motion at at 6 months
Title
measure edema
Description
The edema will be measured with the aid of a measuring tape.
Time Frame
the edema assessment at 6 months
Title
measure functionality
Description
The functionality will be measured with Chewing Quality Assessment Questionnaire
Time Frame
measure Functionality at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela A Biasotto-Gonzalez
Phone
+5511999063166
Email
biasottogonzalez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itana L Spinato
Organizational Affiliation
Universidade Federal do Ceará
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic School of the University Center Estácio do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60125-160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itana Lisane Spinsto, Master

12. IPD Sharing Statement

Learn more about this trial

Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

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