TENS and Orthognathic Surgery | NCT05717322

Studies
TENS and Orthognathic Surgery

NCT05717322

Sponsor

Fayoum University

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Orthognathic Surgery

Interventions

TENS
sham TENS

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2023Actual

Primary Completion Date

Jan 22, 2024Estimated

Completion Date

Jan 30, 2024Estimated

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Feb 3, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shaimaa Mohsen, lecturer of oral and maxillofacial surgery, Fayoum UniversityPrincipal Investigator

Lead Sponsor

Fayoum UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TENS arm	Experimental		Behavioral: TENS
non TENS arm	Active Comparator		Behavioral: sham TENS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TENS	Behavioral	apply TENS after orthognathic surgery	TENS arm
sham TENS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximum mouth opening	will be measured by caliber between the incisal edges of upper and lower centrals	6 months

Secondary Outcomes

Measure	Description	Time Frame
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
muscle activity	measured by EMG at the same time points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shaimaa Refahee	Contact	01227407987		smr11@fayoum.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum University	Recruiting	Al Fayyum			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D004561	Transcutaneous Electric Nerve Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided