Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

Study 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.

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

Conditions
-----------------
Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism

Intervention / Treatment
-----------------
* Behavioral: sensory retraining protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function. | |
| Experimental: sensory retraining group<br>Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed. | Behavioral: sensory retraining protocol<br>* 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<br>* Other names: sensory retraining;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory function test | The sensory function evaluation include objective and subjective examinations as the followings: Questionnaire Visual analogue scale (VAS) Two-point discrimination (2PD) Pain detection threshold (PD) tests Touch sensory threshold | one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mandibular Nerve, Orthognathic Surgery, Sagittal Split Osteotomy, Sensory Retraining