Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237042
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2005-10-07
Brief Title:
Managing Temporomandibular Disorder TMD Symptoms
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Hormonal Cycles in Women Effects on TMD Pain Symptoms
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIDCR-16212 | OTHER_GRANT | National Institute of Dental and Craniofacial Research NIDCR | httpsreporternihgovquickSearch5R01DE016212 |
| R01DE016212 | NIH | None | None |
| 5R01DE016212 | NIH | None | None |