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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00078507
First received: March 1, 2004
Last updated: February 2, 2010
Last verified: February 2010
  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
Behavioral: Sensory Re-training
Behavioral: Sensory Retraining
Behavioral: Opening Exercises
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Re-Training Following Orthognathic Surgery

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

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

Enrollment: 186
Study Start Date: December 2001
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00078507     History of Changes
Other Study ID Numbers: NIDCR-13967, R01DE013967
Study First Received: March 1, 2004
Last Updated: February 2, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 20, 2014