Mandibular AdvancementPhase 3NCT00078507
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
A Phase 3 study testing Sensory Re-training, Sensory Retraining and Opening Exercises in people with Mandibular Advancement, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Mandibular Advancement
- What is being tested?
- Sensory Re-training, Sensory Retraining and Opening Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2001to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Developmental dentofacial disharmony
- Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
School of Dentistry
Chapel Hill, North Carolina, 27599
University Oral and Maxillofacial Surgery
Charlotte, North Carolina, 28211
About this study
Official title: 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.
Read the 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.
- Conditions
- Mandibular Advancement
- Being tested
- Sensory Re-training, Sensory Retraining, Opening Exercises
- Keywords
- Outcome and Process Assessment (Health Care), Behavior Control, Sensation, Randomized Controlled Trials, Adolescent, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Re-trainingBehavioural
Sensory RetrainingBehavioural
Facial Exercises
Opening ExercisesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Opening Exercises Only | Active comparator | Standard of care opening exercises following BSSO surgery to regain mouth opening Receives: Behavioral: Opening Exercises |
| Sensory Retraining Exercises | 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. Receives: Behavioral: Sensory Re-training; Behavioral: Sensory Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of altered sensation
Perception of altered function
Two-point threshold
Two point discrimination
Contact detection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2004 (estimated)
- Study startDec 2001
- Primary completionJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular AdvancementStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Ceib Phillips, DR, Principal investigator, Chapel Hill, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078507
- Sponsor's protocol ID
- NIDCR-13967
- Other IDs
- R01DE013967
- Status last verified
- Feb 2010
- First submitted
- 1 Mar 2004
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Re-Training Following Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT00078507
- Acronym / sponsor ID
- NIDCR-13967
- Conditions
- Mandibular Advancement
- Keywords
- Outcome and Process Assessment (Health Care), Behavior Control, Sensation, Randomized Controlled Trials, Adolescent, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Dec 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 3 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opening Exercises Only | Active comparator | Behavioral: Opening ExercisesStandard of care opening exercises following BSSO surgery to regain mouth opening |
| Sensory Retraining Exercises | Experimental | Behavioral: Sensory Re-training, Behavioral: Sensory Retraining3 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. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Developmental dentofacial disharmony
- Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Re-training | Behavioural | Sensory Retraining Exercises |
| Sensory RetrainingFacial Exercises | Behavioural | Sensory Retraining Exercises |
| Opening Exercises | Behavioural | Opening Exercises Only |
Primary outcome
Perception of altered sensation
Perception of altered function
Two-point threshold
Two point discrimination
Contact detection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
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Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceib Phillips, DR principal investigator
Chapel Hill, School of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sensory Re-training, Sensory Retraining and Opening Exercises in people with Mandibular Advancement, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of altered sensation. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2010.