TENS and Orthognathic Surgery

NCT ID: NCT05717322

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-22

Study Completion Date

2024-01-30

Brief Summary

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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

Detailed Description

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Conditions

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Orthognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TENS arm

Group Type EXPERIMENTAL

TENS

Intervention Type BEHAVIORAL

apply TENS after orthognathic surgery

non TENS arm

Group Type ACTIVE_COMPARATOR

sham TENS

Intervention Type BEHAVIORAL

apply non active TENS after orthognathic surgery

Interventions

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TENS

apply TENS after orthognathic surgery

Intervention Type BEHAVIORAL

sham TENS

apply non active TENS after orthognathic surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohsen

lecturer of oral and maxillofacial surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shaimaa Refahee

Role: CONTACT

01227407987

Facility Contacts

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shaimaa refahee, phd

Role: primary

01227407987

Other Identifiers

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EC2227

Identifier Type: -

Identifier Source: org_study_id

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