Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedApril 27, 2012
April 1, 2012
2.4 years
February 15, 2012
April 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensory function test
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
Study Arms (2)
control group
NO INTERVENTIONNo intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function.
sensory retraining group
EXPERIMENTALSensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed.
Interventions
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
Eligibility Criteria
You may qualify if:
- Taiwanese adult (18-40 y/o)
- Developmental dentofacial disharmony (Class III)
- Patients received orthognathic surgery (BSSO alone or with maxillary procedure)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiung Shing Huang, PhD, DDS
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
April 27, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2015
Last Updated
April 27, 2012
Record last verified: 2012-04