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Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00078507
  Purpose

The purpose of this study is to determine whether facial exercises in conjunction with opening exercises routinely provided after facial surgery to correct a facial skeletal disharmony will shorten the time until a patient receives no unpleasant or negative facial sensation.


Condition Intervention Phase
Mandibular Advancement
Procedure: Sensory Re-training
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Sensory Re-Training Following Orthognathic Surgery

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Perception of altered sensation
  • Perception of altered function
  • Two-point threshold
  • Two point discrimination
  • Contact detection

Estimated Enrollment:   220
Study Start Date:   December 2001
Estimated Study Completion Date:   March 2007

Detailed Description:

Abnormal facial sensation has a negative impact on patients' oral behaviors and may adversely affect a patient's quality of life if the altered sensation persists. Many patients with abnormal sensations retain some sensory function and do not develop chronic pain, and for those individuals there are currently no evidence-based noninvasive therapies. The goal of this project is to evaluate sensory re-training, a rehabilitative therapy that offers significant potential for patients who experience impaired sensory function regardless of the cause. This behavioral therapy approach has been used with substantial clinical success with hand injury patients since the 1970s. Re-training appears to enhance central reorganization of impulses from an injured sensory nerve to the cerebral cortex so that the altered sensory signals can be interpreted and translated into functionally meaningful motor functions.

Sensory re-training will be compared to a placebo jaw-opening exercise in a single blind, randomized two-arm parallel group stratified block clinical trial, using orthognathic surgery patients as subjects. Orthognathic surgery patients offer an uncompromised model for the evaluation of new rehabilitative therapies. These healthy individuals, treated to correct dentofacial deformity, present for surgery with no neurosensory impairment, but yet routinely experience substantial alterations in facial sensation following the surgical procedure. The effects of sensory re-training will be evaluated using three types of outcomes: patient-centered measures to assess the magnitude of the negative effect of altered sensation after surgery and the recovery time needed to reach little or no negative effect; neurosensory behavior measures to assess the patient's ability to learn alternate cues for touch perception and discrimination; and a conventional neurosensory contact threshold measure to assess the actual deficit. Our primary focus will be on the patient's perception of the negative impact of altered sensation on daily life.

  Eligibility
Ages Eligible for Study:   13 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Developmental dentofacial disharmony
  • Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure.

Exclusion Criteria:

  • Congenital anomaly or acute trauma affecting the face.
  • Previous facial surgery
  • Pregnant at baseline
  • Inability to follow written English instructions
  • Unwilling to sign informed consent.
  • No altered sensation at one week post-surgery
  • Altered sensation at baseline reported as numbness or unusual feeling.
  • Medical condition associated with systemic neuropathy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078507

Locations
United States, North Carolina
School of Dentistry    
      Chapel Hill, North Carolina, United States, 27599
University Oral and Maxillofacial Surgery    
      Charlotte, North Carolina, United States, 28211

Sponsors and Collaborators

Investigators
Principal Investigator:     Ceib Phillips, DR     Chapel Hill, School of Dentistry    
  More Information

Study ID Numbers:   NIDCR-13967
First Received:   March 1, 2004
Last Updated:   September 14, 2006
ClinicalTrials.gov Identifier:   NCT00078507
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Outcome and Process Assessment (Health Care)  
Behavior Control  
Sensation  
Randomized Controlled Trials
Adolescent
Adult

Study placed in the following topic categories:
Facies

ClinicalTrials.gov processed this record on August 21, 2008




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