TENS and Orthognathic Surgery

Not Applicable

Recruiting

• Conditions: Orthognathic Surgery
• Interventions: Behavioral: TENS; Behavioral: sham TENS

• Registration Number: NCT05717322
• Lead Sponsor: Fayoum University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-22
• Study First Submitted: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-01-22
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS arm	TENS	-
non TENS arm	sham TENS	-

Primary Outcome Measures

Name	Time	Method
maximum mouth opening	6 months	will be measured by; caliber between the incisal edges of upper and lower centrals

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt