Evaluation of Temporomandibular Disorders During Pregnancy

Sponsor
Zeynep Serra Kalkan
Study ID
NCT07791173
Status
Not Yet Recruiting

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Conditions

  • Pregnancy
  • Temporomandibular Disorders (TMD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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/TMD 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.

Primary Outcome Measure

Change in Graded Chronic Pain Scale - Characteristic Pain Intensity (GCPS-CPI) Score [ Time Frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32), approximately 20-24 week ]

Central Contacts

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