Trial record 5 of 14 for:    Temporomandibular Joint Disorders | NIH

Managing Temporomandibular Disorder (TMD) Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237042
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : July 11, 2011
Last Update Posted : July 11, 2011
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of Washington

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Temporomandibular Joint Disorders
Interventions: Behavioral: Self Management
Behavioral: Targeted Self Management
Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel

  Participant Flow

  Baseline Characteristics

Population Description
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.
No text entered.

Reporting Groups
Self Management Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
Targeted Self Management Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
Continuous Oral Contraceptives 20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
Total Total of all reporting groups

Baseline Measures
   Self Management   Targeted Self Management   Continuous Oral Contraceptives   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   47   49   147 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   51   47   49   147 
>=65 years   0   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 29.1  (7.4)   25.4  (5.7)   28.6  (6.9)   27.8  (6.9) 
[Units: Participants]
Female   51   47   49   147 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   51   47   49   147 

  Outcome Measures

1.  Primary:   Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)   [ Time Frame: 6 months ]

2.  Primary:   Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)   [ Time Frame: 12 months ]

3.  Secondary:   Number of Participants With Pain-Related Activity Interference   [ Time Frame: 6 Months ]

4.  Secondary:   Number of Participants With Pain-Related Activity Interference   [ Time Frame: 12 months ]

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

Certain Agreements:  
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:  
Name/Title: Dr. Judith Turner
Organization: University of Washington
phone: 206-543-3997

Responsible Party: Dr. Linda LeResche, Principal Investigator, University of Washington Identifier: NCT00237042     History of Changes
Other Study ID Numbers: 27729-D
R01DE016212 ( U.S. NIH Grant/Contract )
5R01DE016212 ( U.S. NIH Grant/Contract )
NIDCR-16212 ( Other Grant/Funding Number: National Institute of Dental and Craniofacial Research (NIDCR) )
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: May 2, 2011
Results First Posted: July 11, 2011
Last Update Posted: July 11, 2011