Levonorgestrel Adverse Reaction, Temporomandibular Disorder, Temporomandibular Joint Disorders
Conditions
Keywords
Mirena, Levonorgestrel, Intrauterine system, Temporomandibular disorder
Brief summary
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_TESTExamination 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, and digastric muscles, as well as maximum interincisal distance, restriction of laterotrusion and protrusive movements, joint sounds, deviation or deflection during mouth opening, and the visual analogue score (VAS) for pain in the TMJ.
Sponsors
Marmara University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of temporomandibular joint disorder and masticator muscle pain | One Day | To measure whether there is any difference in the incidence of temporomandibular joint disorders and masticator muscle pain between two groups. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSerhat Can, Specialist
Backup ContactSinem Busra Kirac Can, Specialist
Outcome results
None listed