Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Examination of temporomandibular joint and masticator muscles

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group of patients using levonorgestrel intrauterine systemExperimental treatment 1 intervention
Group B: Control group of healthy patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of temporomandibular joint disorder and masticator muscle pain

To measure whether there is any difference in the incidence of temporomandibular joint disorders and masticator muscle pain between two groups.

Time frame
One Day

Secondary outcomes

Other outcomes

Sponsors and contacts

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