Conservative Treatment of Patients With Temporomandibular Disorders (D1P2-TMD)
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|ClinicalTrials.gov Identifier: NCT01021306|
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : November 17, 2014
Last Update Posted : May 22, 2017
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment|
Device: Chiropractic w/Activator & Self Care
Device: Dental Care & Self Care
Other: Sham AMCT
Other: Self-Care Only Group
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
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|Chiropractic w/Activator & Self Care||
This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw.
|Dental Care & Self Care||
Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i
|Sham AMCT & Self Care||
This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient.
|Self-care Only Group||
All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction.
|Total||Total of all reporting groups|
|Chiropractic w/Activator & Self Care||Dental Care & Self Care||Sham AMCT & Self Care||Self-care Only Group||Total|
Overall Participants Analyzed
Mean (Standard Deviation)
|31.7 (7.9)||36.9 (13.5)||33.1 (11.4)||38.0 (12.7)||35.0 (11.7)|
Sex: Female, Male
Count of Participants
|Female||16 80.0%||17 85.0%||15 78.9%||16 76.2%||64 80.0%|
|Male||4 20.0%||3 15.0%||4 21.1%||5 23.8%||16 20.0%|
Region of Enrollment
|1. Primary:||Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) [ Time Frame: 2 months ]|
|2. Secondary:||Oral Health Impact Profile (OHIP-14) [ Time Frame: 2 months ]|
|3. Secondary:||Bothersomeness of Symptoms [ Time Frame: 2 months ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
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|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
Results Point of Contact:
Organization: Palmer Center for Chiropractic Research, Palmer College of Chiropractic
Publications of Results:
|Responsible Party:||Palmer College of Chiropractic|
|ClinicalTrials.gov Identifier:||NCT01021306 History of Changes|
|Other Study ID Numbers:||
5U19AT004663-02 ( U.S. NIH Grant/Contract )
|First Submitted:||November 24, 2009|
|First Posted:||November 26, 2009|
|Results First Submitted:||October 31, 2014|
|Results First Posted:||November 17, 2014|
|Last Update Posted:||May 22, 2017|