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

Sensory Re-Training Following Orthognathic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Advancement
• Intervention / Treatment: Behavioral: Opening Exercises; Behavioral: Sensory Re-training; Behavioral: Sensory Retraining

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
• Enrollment (Actual): 186
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Perception of altered sensation
Perception of altered function
Two-point threshold
Two point discrimination
Contact detection

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Ceib Phillips, DR, Chapel Hill, School of Dentistry

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: March 1, 2004
• First Submitted That Met QC Criteria: March 2, 2004
• First Posted (Estimate): March 3, 2004

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Adolescent; Randomized Controlled Trials; Adult; Sensation; Outcome and Process Assessment (Health Care); Behavior Control
• Other Study ID Numbers: NIDCR-13967; R01DE013967 (U.S. NIH Grant/Contract)