Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Injury of Trigeminal Nerve Surgery Mandibular Prognathism Behavioral: sensory retraining protocol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
Study Start Date : April 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

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 Name: sensory retraining




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586598


Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chiung Shing Huang, PhD, DDS Chang Gung Memorial Hospital

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01586598     History of Changes
Other Study ID Numbers: CGMH-IRB-100-2302A3
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Chang Gung Memorial Hospital:
Mandibular Nerve
Orthognathic Surgery
Sagittal Split Osteotomy
Sensory Retraining
Additional relevant MeSH terms:
Layout table for MeSH terms
Prognathism
Malocclusion, Angle Class III
Trigeminal Nerve Injuries
Wounds and Injuries
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Malocclusion
Tooth Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System