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NCT Number: NCT07791173

Evaluation of Temporomandibular Disorders During Pregnancy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location contact

Burcu Dincgez, Medical Doctor

CONTACT

[email protected]

+905305448828

Zeynep S Kalkan, Dentist

CONTACT

[email protected]

+905334651698

Zeynep S Kalkan, Dentist

PRINCIPAL_INVESTIGATOR

About this study

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.

This 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/TMD 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-40 years
  • Singleton, healthy pregnancy
  • Presenting to the Obstetrics and Gynecology outpatient clinic during the first trimester (weeks 8-12)
  • No history of systemic rheumatic disease, chronic pain syndrome, or serious psychiatric illness
  • No prior orthodontic treatment
  • Written informed consent after being informed about the purpose and scope of the study

Exclusion criteria

  • Prior treatment for temporomandibular disorders (splint, botulinum toxin, surgery, etc.)
  • History of maxillofacial trauma or temporomandibular joint surgery
  • Systemic rheumatic disease, connective tissue disease, or chronic pain syndrome
  • Use of systemic corticosteroids or hormone replacement therapy
  • Pregnancy achieved through assisted reproductive techniques (e.g., IVF)
  • Refusal to consent to blood sampling or questionnaire administration
  • Language barrier preventing understanding and completion of Turkish-language questionnaires

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Change in Jaw Functional Limitation Scale-8 (JFLS-8) Score

    Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)

    JFLS-8 assesses jaw-related functional limitation in mastication, mobility, and verbal/emotional expression. Higher scores indicate greater functional limitation.

  2. Change in DC/TMD Axis I Clinical Findings

    Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32

    Clinical findings including maximum mouth opening, lateral/protrusive movement range, palpation pain, and joint sounds, assessed per the DC/TMD short protocol.

  3. PSS-10

    Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)

    PSS-10 measures the degree to which situations in one's life are appraised as stressful. Higher scores indicate greater perceived stress.

  4. Change in Systemic Immune-Inflammation Index (SII)

    Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)

    SII will be calculated from routine complete blood count parameters (neutrophil, lymphocyte, and platelet counts) as: SII = (Platelet count × Neutrophil count) / Lymphocyte count.

  5. Change in Serum Estrogen and Progesterone Levels

    Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Agaoglu, Dentist

CONTACT

[email protected]

+90543 433 06 06

Zeynep S Kalkan, Dentist

CONTACT

[email protected]

+905334651698

Sponsors and collaborators

Lead sponsor

Zeynep Serra Kalkan

Other

Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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