Evaluation of Temporomandibular Disorders During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorZeynep Serra Kalkan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Pregnant Women
Trial outcomes
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.
Time frame
From first trimester (weeks 8-12) to third trimester (weeks 28-32), approximately 20-24 weekSecondary outcomes
1
Change in Jaw Functional Limitation Scale-8 (JFLS-8) Score
JFLS-8 assesses jaw-related functional limitation in mastication, mobility, and verbal/emotional expression. Higher scores indicate greater functional limitation.
Time frame
From first trimester (weeks 8-12) to third trimester (weeks 28-32)2
Change in DC/TMD Axis I Clinical Findings
Clinical findings including maximum mouth opening, lateral/protrusive movement range, palpation pain, and joint sounds, assessed per the DC/TMD short protocol.
Time frame
From first trimester (weeks 8-12) to third trimester (weeks 28-323
PSS-10
PSS-10 measures the degree to which situations in one's life are appraised as stressful. Higher scores indicate greater perceived stress.
Time frame
From first trimester (weeks 8-12) to third trimester (weeks 28-32)4
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) / Lymphocyte count.
Time frame
From first trimester (weeks 8-12) to third trimester (weeks 28-32)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zeynep Serra Kalkan
Lead sponsor
Biruni University
Sponsor institution
Bursa Yuksek Ihtisas Training and Research Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: