Clinical trial NCT00078507: Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
Official title: Sensory Re-Training Following Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mandibular Advancement
Keywords: Outcome and Process Assessment (Health Care)
Behavior Control
Sensation
Randomized Controlled Trials
Adolescent
Adult
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2004-03-03
Enrollment: 186
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Perception of altered sensation
measure: Perception of altered function
measure: Two-point threshold
measure: Two point discrimination
measure: Contact detection
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: School of Dentistry
state: North Carolina
city: Charlotte
country: United States
facility: University Oral and Maxillofacial Surgery
state: North Carolina
Study officials:
affiliation: Chapel Hill, School of Dentistry
name: Ceib Phillips, DR
role: PRINCIPAL_INVESTIGATOR
References: