Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
Primary Purpose
Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
sensory retraining protocol
Sponsored by
About this trial
This is an interventional supportive care trial for Injury of Trigeminal Nerve focused on measuring Mandibular Nerve, Orthognathic Surgery, Sagittal Split Osteotomy, Sensory Retraining
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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
sensory retraining group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01586598
First Posted
February 15, 2012
Last Updated
April 25, 2012
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01586598
Brief Title
Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
Official Title
Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism
Keywords
Mandibular Nerve, Orthognathic Surgery, Sagittal Split Osteotomy, Sensory Retraining
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function.
Arm Title
sensory retraining group
Arm Type
Experimental
Arm Description
Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed.
Intervention Type
Behavioral
Intervention Name(s)
sensory retraining protocol
Other Intervention Name(s)
sensory retraining
Intervention Description
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 Outcome Measure Information:
Title
sensory function test
Description
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
Time Frame
one year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiung Shing Huang, PhD, DDS
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
12. IPD Sharing Statement
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Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
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