Managing Temporomandibular Disorder (TMD) Symptoms

University of Washington

Status: Completed

Conditions: Temporomandibular Joint Disorders

Treatments: Behavioral: Targeted Self Management; Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel; Behavioral: Self Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00237042

R01DE016212 (U.S. NIH Grant/Contract)

5R01DE016212 (U.S. NIH Grant/Contract)

NIDCR-16212 (Other Grant/Funding Number)

27729-D

Details and patient eligibility

About

The purpose of this study is to determine whether treatments targeted to the hormonal factors and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in relieving TMD pain and symptoms than standard self management treatment.

Full description

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.

Enrollment: 252 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TMD Pain Diagnosis as determined by enrollment exam at the University of Washington
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 3 patient groups

Self Management

Active Comparator group

Description:

Dental hygienist-delivered pain self-management treatment

Treatment:

Behavioral: Self Management

Targeted Self Management

Experimental group

Description:

Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms

Treatment:

Behavioral: Targeted Self Management

Continuous Oral Contraceptives

Experimental group

Description:

Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "spacer pills."

Treatment:

Drug: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel