Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
NCT ID: NCT06500390
Last Updated: 2024-11-25
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-15
2024-12-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group of patients using levonorgestrel intrauterine system
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.
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.
Control group of healthy patients
The control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Locations
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Marmara University
Istanbul, Maltepe, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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mirena
Identifier Type: -
Identifier Source: org_study_id
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