Investigating the link between levonorgestrel intrauterine system and temporomandibular disorders
Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System
This study is trying to see if using a specific birth control device called the levonorgestrel intrauterine system is linked to jaw joint problems in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Maltepe) |
| Trial ID | NCT06500390 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the potential relationship between the use of the levonorgestrel intrauterine system (LIU) and the occurrence of temporomandibular joint disorders (TMD) in women. It involves two groups: one consisting of women who have used the LIU for at least three months and a control group of healthy women with regular menstrual cycles. The study will compare the frequency of temporomandibular dysfunction between these two groups to determine if there is a significant association. A total of 60 participants will be examined for their temporomandibular joint and masticator muscles.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-50 who have been using a levonorgestrel intrauterine device for at least three months.
Not a fit: Patients with craniofacial syndromes, head and neck trauma history, or other specific exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and side effects of the levonorgestrel intrauterine system, particularly regarding its impact on temporomandibular disorders.
How similar studies have performed: While this study explores a specific association, similar studies have not extensively investigated the relationship between levonorgestrel intrauterine systems and temporomandibular disorders, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being a woman * Having used an intrauterine device for at least 3 months * Being between the ages of 18-50 * Being in American Society of Anesthesiologists-1 and American Society of Anesthesiologists-2 systemic status Exclusion Criteria: * Patients with craniofacial syndrome * Patients with a history of head and neck trauma * Isolated muscle tenderness or previous surgery on TMJ * Patients with rheumatological disorders * Patients with an additional gynecological disease other than endometriosis * Lack of cooperation with the patient.
Where this trial is running
Istanbul, Maltepe
- Marmara University — Istanbul, Maltepe, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Serhat Can, Specialist
- Email: drserhatcan@gmail.com
- Phone: +905556161166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.