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Completed Not applicable Interventional Accepts healthy volunteers

An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)

ClinicalTrials.gov ID: NCT00952900

Public ClinicalTrials.gov record NCT00952900. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

An Implementation and Biobehavioral Study of TMJMD

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

With the great economic costs and traditionally poor outcomes among chronic temporomandibular joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the acute state, in order to prevent these more chronic disability problems. This has been the goal of two past funded grant projects. Results of the initial project isolated risk factors that successfully predicted the development of chronicity with a 91% accuracy rate. A statistical algorithm was developed which was used in the second project to screen out "high-risk" patients. These patients were then randomly assigned an early intervention or non-intervention group. One-year follow-up evaluations documented the treatment efficacy and cost effectiveness of early intervention. These results have major implications for effective early intervention and significant health care cost savings for this prevalent pain and disability problem. For the present proposed project, we plan to implement this treatment program in order to evaluate its effectiveness in more community-based dental practices. This is in response to NIH's request for the implementation of evidence-based treatment approaches, developed in controlled clinical settings, to the "real world" of diverse practices in the community. Acute TMJMD patients will be recruited from two community-based clinics. Based upon our "risk" screening algorithm, high-risk patients will be randomly assigned to one of two groups (n=225/group): an early biobehavioral intervention or an attention-control group. It is hypothesized that the attention control "high-risk" patients will display more chronic TMJMD problems, relative to the "high-risk" early intervention patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc. Such a multi-level, multi-systems approach has not been applied to better understand the biopsychosocial underpinnings of TMJMD. Results from this component of the project will greatly aid in stimulating future research leading to the better understanding of TMJMD, as well as better tailoring of prescribed treatment regimens.

Study identification

NCT ID
NCT00952900
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
456 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2008
Primary completion
Sep 30, 2013
Completion
Jun 30, 2014
Last update posted
Jun 7, 2015

2008 – 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UT Arlington Arlington Texas 76019

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00952900, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2015 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00952900 live on ClinicalTrials.gov.

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