Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

Not Applicable

Recruiting

• Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder; Levonorgestrel Adverse Reaction
• Interventions: Diagnostic Test: Examination of temporomandibular joint and masticator muscles

• Registration Number: NCT06500390
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Primary Completion: 2024-04-15
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of patients using levonorgestrel intrauterine system	Examination of temporomandibular joint and masticator muscles	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.
Control group of healthy patients	Examination of temporomandibular joint and masticator muscles	The control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Maltepe, Turkey