[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653779":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":37,"interventions":31,"overallOfficials":31,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":31,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":31,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":103,"whyStopped":31,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Biruni University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Graded Chronic Pain Scale - Characteristic Pain Intensity (GCPS-CPI) Score","The GCPS-CPI subscale assesses characteristic pain intensity related to temporomandibular disorders. Scores range from 0 to 100, with higher scores indicating greater pain intensity. The change between the first and third trimester assessments will be evaluated.","From first trimester (weeks 8-12) to third trimester (weeks 28-32), approximately 20-24 week",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Change in Jaw Functional Limitation Scale-8 (JFLS-8) Score","JFLS-8 assesses jaw-related functional limitation in mastication, mobility, and verbal\u002Femotional expression. Higher scores indicate greater functional limitation.","From first trimester (weeks 8-12) to third trimester (weeks 28-32)",{"measure":19,"description":20,"timeFrame":21},"Change in DC\u002FTMD Axis I Clinical Findings","Clinical findings including maximum mouth opening, lateral\u002Fprotrusive movement range, palpation pain, and joint sounds, assessed per the DC\u002FTMD short protocol.","From first trimester (weeks 8-12) to third trimester (weeks 28-32",{"measure":23,"description":24,"timeFrame":17},"PSS-10","PSS-10 measures the degree to which situations in one's life are appraised as stressful. Higher scores indicate greater perceived stress.",{"measure":26,"description":27,"timeFrame":17},"Change in Systemic Immune-Inflammation Index (SII)","SII will be calculated from routine complete blood count parameters (neutrophil, lymphocyte, and platelet counts) as: SII = (Platelet count × Neutrophil count) \u002F Lymphocyte count.",{"measure":29,"description":30,"timeFrame":17},"Change in Serum Estrogen and Progesterone Levels","Venous blood samples will be analyzed for serum estrogen and progesterone concentrations, where participants provide additional consent. Hormonal data may not be available for all enrolled participants.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Pregnancy is characterized by significant hormonal, biomechanical, and psychosocial changes. Rising estrogen and progesterone levels may affect connective tissue, joint stability, and pain perception, and estrogen receptors have been identified in temporomandibular joint tissue, suggesting a biological pathway linking pregnancy hormones to TMD symptoms.\n\nThis prospective longitudinal cohort study will enroll 60 pregnant women aged 18-40 who are in their first trimester at the time of enrollment. Clinical TMD findings will be assessed using the DC\u002FTMD short protocol; pain and functional limitation will be measured with the Graded Chronic Pain Scale (GCPS) and Jaw Functional Limitation Scale-8 (JFLS-8); psychosocial status will be assessed with the Perceived Stress Scale (PSS-10) and Oral Behaviors Checklist (OBC). Venous blood samples will be drawn at both visits as part of routine complete blood count testing, from which a Systemic Immune-Inflammation Index (SII) will be calculated for all participants. Where participants provide additional consent, blood samples will also be used to measure serum estrogen and progesterone levels; hormonal data may therefore not be available for all enrolled participants. Occlusal relationships (Angle classification) will be recorded as a secondary, exploratory variable. The primary outcome is the change in GCPS pain intensity score between the first and third trimester.","Pregnant women aged 18-40 years presenting to the Obstetrics and Gynecology outpatient clinic during their first trimester, recruited consecutively based on eligibility criteria.",[38],{"label":39,"type":31,"description":40,"interventionNames":31},"Pregnant Women","Healthy, singleton pregnant women aged 18-40 years, enrolled in their first trimester (weeks 8-12) and followed prospectively through the third trimester (weeks 28-32). Participants underwent clinical DC\u002FTMD examination, pain and functional assessment (GCPS, JFLS-8), psychosocial questionnaires (PSS-10, OBC), and blood collection for complete blood count (with SII calculation) at both visits. Where additional consent was provided, blood samples were also used to measure serum estrogen and progesterone levels. No intervention was administered; this is a purely observational cohort.",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Zeynep S Kalkan, Dentist","CONTACT","+905334651698","dtzeynepserra@gmail.com",{"name":48,"role":44,"phone":49,"phoneExt":31,"email":50},"Esra Agaoglu, Dentist","+90543 433 06 06","emogul@biruni.edu.tr",[52],{"facility":53,"status":31,"city":54,"state":31,"zip":31,"country":55,"countryCode":31,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital","Bursa","Turkey (Türkiye)",{"type":57,"coordinates":58},"Point",[59,60],29.06013,40.19559,{"lat":60,"lon":59},[63,64,68],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},{"name":65,"role":44,"phone":66,"phoneExt":31,"email":67},"Burcu Dincgez, Medical Doctor","+905305448828","burcu.dincgez@sbu.edu.tr",{"name":43,"role":69,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Zeynep Serra Kalkan","Dentist, PhD Candidate",[75],{"name":76,"class":77},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV","100653779","evaluation-of-temporomandibular-disorders-during-pregnancy-100653779",false,"NCT07791173","Evaluation of Temporomandibular Disorders During Pregnancy","Inclusion Criteria:\n\n* Aged 18-40 years\n* Singleton, healthy pregnancy\n* Presenting to the Obstetrics and Gynecology outpatient clinic during the first trimester (weeks 8-12)\n* No history of systemic rheumatic disease, chronic pain syndrome, or serious psychiatric illness\n* No prior orthodontic treatment\n* Written informed consent after being informed about the purpose and scope of the study\n\nExclusion Criteria:\n\n* Prior treatment for temporomandibular disorders (splint, botulinum toxin, surgery, etc.)\n* History of maxillofacial trauma or temporomandibular joint surgery\n* Systemic rheumatic disease, connective tissue disease, or chronic pain syndrome\n* Use of systemic corticosteroids or hormone replacement therapy\n* Pregnancy achieved through assisted reproductive techniques (e.g., IVF)\n* Refusal to consent to blood sampling or questionnaire administration\n* Language barrier preventing understanding and completion of Turkish-language questionnaires","FEMALE","18 Years","40 Years",{"count":88,"type":89},60,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate how temporomandibular disorders (TMD) - a condition affecting the jaw joint and chewing muscles - change during pregnancy. The same pregnant women will be assessed twice: once in the first trimester (weeks 8-12) and again in the third trimester (weeks 28-32). At each visit, researchers will examine jaw function and pain, and collect blood samples to calculate inflammation markers from routine complete blood counts. Where participants additionally consent, blood samples will also be used to measure hormone levels (estrogen and progesterone). Participants will also complete questionnaires about pain, stress and jaw-related habits. The goal is to better understand whether hormonal and inflammatory changes during pregnancy are associated with the development or worsening of TMD symptoms.",[93,94],"Temporomandibular Disorders (TMD)","Pregnancy",[96,94,97,98,99,100,101,102],"Temporomandibular Joint Disorders","DC\u002FTMD","Estrogen","Progesterone","Systemic Immune-Inflammation Index","Chronic Pain","Prospective Cohort Study","NOT_YET_RECRUITING","2026-08-25",{"date":106,"type":107},"2026-08-27","ACTUAL",{"date":109,"type":89},"2026-09",{"date":111,"type":89},"2027-05",{"name":72,"class":6},1]