TENS and Orthognathic Surgery

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717322
• Other study ID #: EC2227
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2023
• Source: Fayoum University
• Contact: Shaimaa Refahee
• Phone: 01227407987
• Email: smr11[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 30, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

Behavioral:
• TENS
apply TENS after orthognathic surgery
• sham TENS
apply non active TENS after orthognathic surgery

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum mouth opening	will be measured by; caliber between the incisal edges of upper and lower centrals	6 months
Secondary	visual analogue scale	will be measured by VAS scale at the same time points of mouth opening(0_10) 0 represent no pain,10represent high pain	6months
Secondary	muscle activity	measured by EMG at the same time points	6months