NCT06500390

Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Marmara University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Levonorgestrel Adverse Reaction
• Temporomandibular Joint Disorders
• Temporomandibular Disorder

Interventions

Type	Name	Description
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, 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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-04-15
• Completion: 2024-12-15
• First posted: 2024-07-15
• Last updated: 2024-11-25

Locations

1 site across 1 country: Turkey (Türkiye)