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

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. Identifier: NCT00078507
Recruitment Status : Completed
First Posted : March 3, 2004
Last Update Posted : February 3, 2010
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Mandibular Advancement Behavioral: Sensory Re-training Behavioral: Sensory Retraining Behavioral: Opening Exercises Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Re-Training Following Orthognathic Surgery
Study Start Date : December 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Opening Exercises Only
Standard of care opening exercises following BSSO surgery to regain mouth opening
Behavioral: Opening Exercises
Experimental: Sensory Retraining Exercises
3 sets of facial exercises performed with soft cosmetic brush 1 wk - 4 wks after surgery; 4wks to 3 mos after surgery; 3 mos to 6 mos after surgery.
Behavioral: Sensory Re-training Behavioral: Sensory Retraining
Facial Exercises

Primary Outcome Measures :
  1. Perception of altered sensation
  2. Perception of altered function
  3. Two-point threshold
  4. Two point discrimination
  5. Contact detection

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.

Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00078507

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
University of North Carolina, Chapel Hill
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Ceib Phillips, DR Chapel Hill, School of Dentistry Identifier: NCT00078507     History of Changes
Other Study ID Numbers: NIDCR-13967
R01DE013967 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2004    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by University of North Carolina, Chapel Hill:
Outcome and Process Assessment (Health Care)
Behavior Control
Randomized Controlled Trials