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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

NCT05876169

Cleft Lip and Palate

ENROLLING_BY_INVITATION NA

The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis

NCT03497520

Scoliosis Idiopathic

ACTIVE_NOT_RECRUITING NA

Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance

NCT00497510

Musculoskeletal Equilibrium

COMPLETED NA

Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery

NCT06279377

Cervical Spine Disease Surgery Rehabilitation +1 more

RECRUITING NA

Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception

NCT04945798

Segmental and Somatic Dysfunction of Other Regions (M99.09)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mandibular Advancement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opening Exercises Only

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

Group Type ACTIVE_COMPARATOR

Opening Exercises

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Sensory Re-training

Intervention Type BEHAVIORAL

Sensory Retraining

Intervention Type BEHAVIORAL

Facial Exercises

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sensory Re-training

Intervention Type BEHAVIORAL

Sensory Retraining

Facial Exercises

Intervention Type BEHAVIORAL

Opening Exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No