N/A
N=191
Managing Temporomandibular Disorder (TMD) Symptoms
Temporomandibular Joint Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00237042 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) — 3.1; 2.9; 3.6 units on a scale — p=0.19
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self Management (Behavioral); Targeted Self Management (Behavioral); 20 mcg ethinyl estradiol and 100 mcg levonorgestrel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) |
2.8; 2.8; 3.9 | 0.003 sig |
| PRIMARY Characteristic Pain Intensity (Characteristic Intensity of Facial Pain) |
2.8; 2.8; 3.9 | 0.003 sig |
| SECONDARY Number of Participants With Pain-Related Activity Interference |
19; 17; 30 | 0.016 sig |
| SECONDARY Number of Participants With Pain-Related Activity Interference |
19; 17; 30 | 0.016 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00237042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.