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NCT Number: NCT06500390

Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System

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.

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Key information

Conditions

Levonorgestrel Adverse Reaction Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Disorder Temporomandibular Joint Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sinem Busra Kirac Can

CONTACT

[email protected]

+902167775000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of temporomandibular joint disorder and masticator muscle pain

    Time frame: One Day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Serhat Can, Specialist

CONTACT

[email protected]

+905556161166

Sinem Busra Kirac Can, Specialist

CONTACT

[email protected]

+905064181024

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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