Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Examination of temporomandibular joint and masticator muscles.
- Who it may be relevant to
- Registry conditions: Levonorgestrel Adverse Reaction, Temporomandibular Joint Disorders, Temporomandibular Disorder. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System
Overview
The goal of this clinical trial is to investigate the possible role of levonorgestrel intrauterine system use(LIU) in the pathogenesis of temporomandibular joint disorder (TMD). In this clinical trial, levonorgestrel intrauterine system patients (n=30) aged 25-50 and control group patients (n=30) with the same demographics and age range are used. The main questions it aims to answer are: To compare the frequency of temporomandibular dysfunction in women using the levonorgestrel intrauterine system with the control group of the same demographic and age range. The levonorgestrel intrauterine system use group consisted of 50 women who had previously a mirena implanted by a gynecologist at least 3 months ago due to menstrual bleeding and pelvic pain. The control group included 50 randomised healthy women who had regular menstrual cycles and were not taking any medication.
Interventions
- Diagnostic test Examination of temporomandibular joint and masticator muscles
The TMJ and the masticatory muscles were evaluated by the same clinician. Patients described symptoms such as preauricular pain, limited mouth opening, deviation or deflection during mouth opening, and joint sounds. All patients were assessed using Okeson's Muscle and temporomandibular joint examination and treatment outcome form. This form records (for both TMJ) tenderness and pain in the masseter, temporalis, lateral pterygoid, medial pterygoid, sternocleidomastoid, trapezius, splenius capitis
Primary outcome measures
- Evaluation of temporomandibular joint disorder and masticator muscle pain [Time frame: One Day]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- Marmara University — Istanbul
Publications
- Can S, Can SBK, Karakus SS, Berkel G. Does the use of the levonorgestrel intrauterine system increase the prevalence of masticatory muscles tenderness? Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Oct;140(4):384-390. doi: 10.1016/j.oooo.2025.03.001. Epub 2025 Mar 8. PMID 40393879
Identifiers
NCT: NCT06500390 · mirena