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Home > "S" Clinical Trials Conditions > Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony  Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
For Condition: Mandibular Advancement
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Developmental dentofacial disharmony - Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure. Exclusion Criteria: - Congenatial anomaly or acute trauma affecting the fact. - 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.
Total Enrollment: 220
Location and Contact Information:
University Oral and Maxillofacial Surgery *Recruiting*
Charlotte, North Carolina, 28211
United States
Recruiting Myron Tucker 704-347-0241
School of Dentistry *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting Ceib Phillips 919-966-2763
Additional Information:
Study ID Numbers: NIDCR-13967;
Study Start Date: December 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078507
Other Mandibular Advancement Studies:
1. Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
Related Studies:
Other Mandibular Advancement Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
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