Completed

Sensory Re-Training Following Orthognathic Surgery

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What is being tested

Sensory Re-training

+ Sensory Retraining

+ Opening Exercises

Behavioral
Who is being recruted

From 13 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2001
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitleSensory Re-Training Following Orthognathic Surgery 
NCT00078507
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Standard of care opening exercises following BSSO surgery to regain mouth opening

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

School of Dentistry

Chapel Hill, United StatesSee the location
Suspended

University Oral and Maxillofacial Surgery

Charlotte, United States
Completed2 Study Centers