NCT05717322

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 27, 2023

Last Update Submit

February 3, 2023

Conditions

Orthognathic Surgery

Keywords

orthognathicTENSEMG

Outcome Measures

Primary Outcomes (1)

  • maximum mouth opening

    will be measured by caliber between the incisal edges of upper and lower centrals

    6 months

Secondary Outcomes (2)

  • visual analogue scale

    6months

  • muscle activity

    6months

Study Arms (2)

TENS arm

EXPERIMENTAL
Behavioral: TENS

non TENS arm

ACTIVE COMPARATOR
Behavioral: sham TENS

Interventions

TENSBEHAVIORAL

apply TENS after orthognathic surgery

TENS arm
sham TENSBEHAVIORAL

apply non active TENS after orthognathic surgery

non TENS arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Central Study Contacts

Shaimaa Refahee

CONTACT

01227407987smr11@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 8, 2023

Study Start

January 22, 2023

Primary Completion

January 22, 2024

Study Completion

January 30, 2024

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(1)