This trial is active, not recruiting.

Conditions injury of trigeminal nerve, surgery, mandibular prognathism
Treatment sensory retraining protocol
Sponsor Chang Gung Memorial Hospital
Start date April 2012
End date September 2014
Trial size 80 participants
Trial identifier NCT01586598, CGMH-IRB-100-2302A3


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
(No Intervention)
No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function.
Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed.
sensory retraining protocol sensory retraining
within one month after the surgery: facial massage and physical stimulation over lower face and lip, four times (20 minutes each time) a day one to three months after the surgery: brush and physical stimulation over lower face and lip, four times (20 minutes each time) a day three to six months after the surgery: brush, pin and physical stimulation over lower face and lip, four times (20 minutes each time) a day

Primary Outcomes

sensory function test
time frame: one year after surgery

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

Inclusion Criteria: 1. Taiwanese adult (18-40 y/o) 2. Developmental dentofacial disharmony (Class III) 3. Patients received orthognathic surgery (BSSO alone or with maxillary procedure) Exclusion Criteria: 1. Medical condition associated with systemic neuropathy 2. Unwilling to sign informed consent 3. Congenital anomaly or acute trauma affecting the face 4. Previous facial surgery 5. Positive pain sensation at first week of post-surgery 6. Altered sensation before OGS as numbness or unusual feeling 7. Cleft lip and palate

Additional Information

Official title Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
Principal investigator Chiung Shing Huang, PhD, DDS
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.