Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedFirst Submitted
Initial submission to the registry
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedNovember 25, 2024
November 1, 2024
3 months
July 8, 2024
November 21, 2024
Conditions
Keywords
Outcome Measures
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.
One Day
Study Arms (2)
Group of patients using levonorgestrel intrauterine system
EXPERIMENTALThe 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
EXPERIMENTALThe control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Istanbul, Maltepe, 34854, Turkey (Türkiye)
Related Publications (1)
Can S, Can SBK, Karakus SS, Berkel G. Does the use of the levonorgestrel intrauterine system increase the prevalence of masticatory muscles tenderness? Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Oct;140(4):384-390. doi: 10.1016/j.oooo.2025.03.001. Epub 2025 Mar 8.
PMID: 40393879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2024
First Posted
July 15, 2024
Study Start
January 15, 2024
Primary Completion
April 15, 2024
Study Completion
December 15, 2024
Last Updated
November 25, 2024
Record last verified: 2024-11