Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

April 25, 2012 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10507
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function.
Experimental: sensory retraining group
Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed.
Behavioral: sensory retraining protocol
  1. within one month after the surgery: facial massage and physical stimulation over lower face and lip, four times (20 minutes each time) a day
  2. one to three months after the surgery: brush and physical stimulation over lower face and lip, four times (20 minutes each time) a day
  3. 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
Other Names:
  • sensory retraining

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chiung Shing Huang, PhD, DDS, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMH-IRB-100-2302A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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