Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

Marmara University

Status: Enrolling

Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder; Levonorgestrel Adverse Reaction

Treatments: Diagnostic Test: Examination of temporomandibular joint and masticator muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT06500390

mirena

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group of patients using levonorgestrel intrauterine system

Experimental group

Description:

The levonorgestrel intrauterine system use patients 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.

Treatment:

Diagnostic Test: Examination of temporomandibular joint and masticator muscles

Control group of healthy patients

Experimental group

Description:

The control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication.

Treatment:

Diagnostic Test: Examination of temporomandibular joint and masticator muscles