TENS and Orthognathic Surgery

February 3, 2023 updated by: Shaimaa Mohsen, Fayoum University

The Effect of Transcutaneous Stimulation (TENS) on the Recovery of Muscle Function After Orthognathic Surgery

All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

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

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Recruiting
        • Fayoum University

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class II facial deformity
  • absence of temporomandibular joint pain and preoperative opening mouth limitation
  • normal cranial form
  • presence of dentition
  • Fit to GA

Exclusion Criteria:

  • temporomandibular joint pain and preoperative opening mouth limitation;
  • craniofacial anomalies and abnormal cranial form
  • absence of facial trauma, mandibular condylar fracture

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TENS arm
Behavioral: TENS
apply TENS after orthognathic surgery
ACTIVE_COMPARATOR: non TENS arm
Behavioral: sham TENS
apply non active TENS after orthognathic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum mouth opening
Time Frame: 6 months

will be measured by

caliber between the incisal edges of upper and lower centrals
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 6months
will be measured by VAS scale at the same time points of mouth opening(0_10) 0 represent no pain,10represent high pain
6months
muscle activity
Time Frame: 6months
measured by EMG at the same time points
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

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)

January 22, 2023

Primary Completion (ANTICIPATED)

January 22, 2024

Study Completion (ANTICIPATED)

January 30, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EC2227

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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