Evaluation of Temporomandibular Disorders During Pregnancy

NCT07791173 | Not Yet Recruiting

• 1 other identifier: BIRUNI-ORT-TMJ-PREG-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Disorders (TMD); Pregnancy

Keywords

Temporomandibular Joint Disorders; Pregnancy; DC/TMD; Estrogen; Progesterone; Systemic Immune-Inflammation Index; Chronic Pain; Prospective Cohort Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

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

• Change in DC/TMD Axis I Clinical Findings

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

• PSS-10

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

• Change in Systemic Immune-Inflammation Index (SII)

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

• Change in Serum Estrogen and Progesterone Levels

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18-40 years presenting to the Obstetrics and Gynecology outpatient clinic during their first trimester, recruited consecutively based on eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeynep Serra Kalkan: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Study Sites (1)

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (1)

• Minervini G, Marrapodi MM, La Verde M, Meto A, Siurkel Y, Cicciu M, Russo D. The relationship between pregnancy and temporomandibular disorder (TMD) through diagnostic criteria for temporomandibular disorders (DC/TMD) axis II evaluation: a case-control cross-sectional study. BMC Oral Health. 2024 Mar 16;24(1):342. doi: 10.1186/s12903-024-04009-y.

  PMID: 38493079 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zeynep S Kalkan, Dentist

CONTACT

+905334651698; dtzeynepserra@gmail.com

Esra Agaoglu, Dentist

CONTACT

+90543 433 06 06; emogul@biruni.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist, PhD Candidate

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)