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Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

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ClinicalTrials.gov Identifier: NCT01586598
Recruitment Status : Unknown
Verified April 2012 by Chang Gung Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2012
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2012
First Posted Date  ICMJE April 27, 2012
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
Official Title  ICMJE Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Injury of Trigeminal Nerve
  • Surgery
  • Mandibular Prognathism
Intervention  ICMJE 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 Name: sensory retraining
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: sensory retraining protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586598
Other Study ID Numbers  ICMJE CGMH-IRB-100-2302A3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chiung Shing Huang, PhD, DDS Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP