Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01586598
• Other study ID #: CGMH-IRB-100-2302A3
• Status: Active, not recruiting
• Phase: N/A
• First received: February 15, 2012
• Last updated: April 25, 2012
• Start date: April 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Injury of Trigeminal Nerve
• Malocclusion, Angle Class III
• Mandibular Prognathism
• Prognathism
• Surgery
• Trigeminal Nerve Injuries

Intervention

Behavioral:
• sensory retraining protocol
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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No