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
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Disorders||Device: Chiropractic w/Activator & Self Care Device: Dental Care & Self Care Other: Sham AMCT Other: Self-Care Only Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Conservative Treatment of Patients With Temporomandibular Disorders|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||May 2012|
Active Comparator: Chiropractic w/Activator & Self Care
This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Device: 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.
Active Comparator: Dental Care & Self Care
Intraoral splints are removable orthopedic appliances fabricated of hard acrylic resin positioned between the remaining teeth of the patient. They are designed in theory to support the function of the TMJ and relieve associated pain. Stabilization splints are believed to function by stabilizing the intracapsular structure of the TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Device: Dental Care & Self Care
Following the dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions made. Interocclusal records will be made with a fast setting silicone using a metal tray. A commercial laboratory will then wax and heat process a clear acrylic resin splint attempting to capture the mandibular cusp tips in the occlusal plan of the splint. The splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. The splint will then be polished and home care instruction provided. Patients will be instructed to wear the splint at night and two hours per day.
Sham Comparator: 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.
Other: 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.
Placebo Comparator: 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.
Other: 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.
- Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) [ Time Frame: 2 months ]The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
- Oral Health Impact Profile (OHIP-14) [ Time Frame: 2 months ]The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.
- Bothersomeness of Symptoms [ Time Frame: 2 months ]Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021306
|United States, Iowa|
|Coralville, Iowa, United States, 52241|
|Palmer College of Chirpractic|
|Davenport, Iowa, United States, 52803|
|University of Iowa College of Dentistry|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||James W DeVocht, DC, PhD||Palmer College of Chiropractic|