Levonorgestrel Adverse ReactionNCT06500390
Temporomandibular Disorder in Use of Levonorgestrel Intrauterine System
A study testing Examination of temporomandibular joint and masticator muscles in people with Levonorgestrel Adverse Reaction and Temporomandibular Joint Disorders, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Levonorgestrel Adverse Reaction, Temporomandibular Joint Disorders, Temporomandibular Disorder
- What is being tested?
- Examination of temporomandibular joint and masticator muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, Maltepe, 34854
Sinem Busra Kirac Can, +902167775000, sb.kirac@gmail.com
About this study
Official title: Is the Incidence of Temporomandibular Disorder Increased in the 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.
Read more
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
- Being tested
- Examination of temporomandibular joint and masticator muscles
- Keywords
- Mirena, Levonorgestrel, Intrauterine system, Temporomandibular disorder
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of temporomandibular joint and masticator musclesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Group of patients using levonorgestrel intrauterine system | Experimental | 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. Receives: Diagnostic Test: Examination of temporomandibular joint and masticator muscles |
| Control group of healthy patients | Experimental | The control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication. Receives: Diagnostic Test: Examination of temporomandibular joint and masticator muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Levonorgestrel Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500390
- Sponsor's protocol ID
- mirena
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40393879
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Incidence of Temporomandibular Disorder Increased in the Use of Levonorgestrel Intrauterine System
- ClinicalTrials.gov ID
- NCT06500390
- Acronym / sponsor ID
- mirena
- Conditions
- Levonorgestrel Adverse Reaction, Temporomandibular Joint Disorders, Temporomandibular Disorder
- Keywords
- Mirena, Levonorgestrel, Intrauterine system, Temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of patients using levonorgestrel intrauterine system | Experimental | Diagnostic Test: Examination of temporomandibular joint and masticator musclesThe 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 | Experimental | Diagnostic Test: Examination of temporomandibular joint and masticator musclesThe control group included 50 randomized health women who had regular menstrual cycles and were not taking any medication. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of temporomandibular joint and masticator musclesThe 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. | Diagnostic test | Control group of healthy patients, Group of patients using levonorgestrel intrauterine system |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 40393879Can 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examination of temporomandibular joint and masticator muscles in people with Levonorgestrel Adverse Reaction and Temporomandibular Joint Disorders, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serhat Can, Specialist (+905556161166, drserhatcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of temporomandibular joint disorder and masticator muscle pain (time frame: One Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.