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Completed

NCT Number: NCT00078507

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

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.

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Key information

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

School of Dentistry, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory Re-training

Behavioral

Sensory Retraining

Behavioral

Facial Exercises

Opening Exercises

Behavioral

Primary outcomes

  1. Perception of altered sensation

  2. Perception of altered function

  3. Two-point threshold

  4. Two point discrimination

  5. Contact detection

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Sensory Re-Training Following Orthognathic Surgery

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Mar 3, 2004
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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