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Clinical Trials/NCT01586598
NCT01586598
Unknown
Not Applicable

Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial

Chang Gung Memorial Hospital1 site in 1 country80 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Injury of Trigeminal Nerve
Sponsor
Chang Gung Memorial Hospital
Enrollment
80
Locations
1
Primary Endpoint
sensory function test
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.

Detailed Description

The study is a prospective randomized controlled trial. The patients receiving bilateral sagittal split osteotomy and having lip numbness or paraesthesia will be included in this study. 80 patients will be included and randomized into two groups and there are 40 patients in each group. The control group is to maintain follow up in clinic and do not receive any sensory retraining exercise. The experimental group is requested to perform sensory retraining at home by themselves.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
September 2015
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Taiwanese adult (18-40 y/o)
  • Developmental dentofacial disharmony (Class III)
  • Patients received orthognathic surgery (BSSO alone or with maxillary procedure)

Exclusion Criteria

  • Medical condition associated with systemic neuropathy
  • Unwilling to sign informed consent
  • Congenital anomaly or acute trauma affecting the face
  • Previous facial surgery
  • Positive pain sensation at first week of post-surgery
  • Altered sensation before OGS as numbness or unusual feeling
  • Cleft lip and palate

Outcomes

Primary Outcomes

sensory function test

Time Frame: one year after surgery

The sensory function evaluation include objective and subjective examinations as the followings: 1. Questionnaire 2. Visual analogue scale (VAS) 3. Two-point discrimination (2PD) 4. Pain detection threshold (PD) tests 5. Touch sensory threshold

Study Sites (1)

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