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Managing Temporomandibular Disorder (TMD) Symptoms

This study is currently recruiting patients

Verified by National Institute of Dental and Craniofacial Research (NIDCR) April 2006

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00237042


Purpose

The purpose of this study is to determine, in a population seeking treatment at a University-based clinic (University of Washington, Seattle, WA), what factors contribute to the cyclicity of TMD pain and symptoms in women, and also to see what treatments are most effective in relieving TMD pain and symptoms.


Condition Intervention
Temporomandibular Joint Disorders Behavior: Cognitive-behavioral (2 arms) and pharmacologic (1 arm)

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Hormonal Cycles in Women: Effects on TMD Pain & Symptoms

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):
Primary Outcomes: Based on diaries: daily levels of TMD pain and severity of cyclic symptoms; global measures of TMD pain severity and pain related interference
Expected Total Enrollment:  240

Study start: October 2005;  Expected completion: December 2009
Last follow-up: June 2009;  Data entry closure: September 2009

Temporomandibular disorders (TMD) are a group of painful conditions involving the muscles of mastication and the temporomandibular joint. These pain problems are about twice as common in women as in men in the community, and prevalence peaks during the reproductive years. The etiology of TMD pain is unknown, but psychological stress, depression and the presence of other somatic complaints have been shown to influence the course of these disorders. Prior research suggests that female reproductive hormones may also influence TMD pain. Specifically, normally cycling women with TMD experience rising levels of TMD pain pre-menstrually during a time of precipitous drop in estrogen and show peak TMD pain during menses. Interestingly, a secondary peak of TMD pain occurs at about the time of ovulation, another phase corresponding to rapid estrogen change. These data demonstrate a systematic relationship between levels of TMD pain and phases of the menstrual cycle. The proposed clinical trial will manipulate the behavioral and hormonal factors that are hypothesized to influence TMD pain, comparing the effects of:

  • a continuous oral contraceptive intervention designed to suppress menses and stabilize the hormonal environment;
  • a self-management intervention focused on and timed to the chronobiology of TMD symptoms across the menstrual cycle; and
  • a usual self-management intervention not timed to biological events. The aims of this clinical trial are to shed light on the mechanisms underlying the cyclic nature of TMD pain and symptoms in women, as well as to determine which treatment modality results in the greatest improvement in TMD pain and symptoms.

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • New patients to the Oral Medicine Clinic, University of Washington, Seattle, WA.
  • TMD pain diagnosis
  • Menstruate on a regular basis
  • Not planning to become pregnant during the next 6 months

Exclusion Criteria:

  • Drug or alcohol abuse
  • Current smoker and 35 years of age at any time during the study
  • Live further than 1 hour driving distance from the University of Washington, Seattle campus
  • Psychiatric disability

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00237042

Linda LeResche, DR      206-616-6049    leresche@u.washington.edu
Judith Turner, DR      206-543-3997    jturner@u.washington.edu

Washington
University of Washington, Seattle,  Washington,  98195-6370,  United States; Recruiting
Linda LeResche  206-616-6049    leresche@u.washington.edu 
Judith Turner, DR  206-543-3997    jturner@u.washington.edu 
Linda LeResche,  Principal Investigator

Study chairs or principal investigators

Linda LeResche,  Principal Investigator,  University of Washington   

More Information

Study ID Numbers:  NIDCR-16212; 5R01-DE016212
Last Updated:  June 8, 2006
Record first received:  October 7, 2005
ClinicalTrials.gov Identifier:  NCT00237042
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-29





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