ClinicalTrials.gg
Not yet recruitingNCT07791173Updated Aug 27, 2026

Evaluation of Temporomandibular Disorders During Pregnancy

An observational study in Temporomandibular Disorders (TMD) and Pregnancy, sponsored by Zeynep Serra Kalkan. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Zeynep Serra Kalkan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 150 studies in Temporomandibular Joint Disorders with a site in Turkey — 27 open to participants now, 28 under way, none of them phase 3. Temporomandibular Joint Disorders · Turkey.

Planned enrollment
44th of 70
60 · median 78
Started
2026
with 14 others
Observational
70 of 150
14 open now
Primary completion
2027-03
later than 27 of 27 live
Registered
147th of 150
by date

Among the 150 studies in Temporomandibular Joint Disorders with a site in Turkey, this one is the 44th largest by planned enrollment of the 70 observational ones, is one of 15 that started in 2026, is one of 70 observational ones, reaches primary completion later than 27 of the 27 other live ones, and was the 147th registered.

By phase

150 studies; the count open now beside each. This study's row is marked.

No phase76 · 13 open
Observationalthis study70 · 14 open
Phase 43 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2011; this study’s year is marked. 15 started in 2026.

Size and results

Median enrollment 45 across the 80 interventional studies, 78 across the 70 observational. Of the 114 that completed or were terminated, 4 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 150 studies in Temporomandibular Joint Disorders with a site in Turkey, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Temporomandibular Disorders (TMD)
  • Pregnancy

Keywords

  • Temporomandibular Joint Disorders
  • Pregnancy
  • DC/TMD
  • Estrogen
  • Progesterone
  • Systemic Immune-Inflammation Index
  • Chronic Pain
  • Prospective Cohort Study
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 after being informed about the purpose and scope of the study

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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 week

Secondary 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 28-32

  3. 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)

  5. 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.

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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 38493079 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to data protection and confidentiality commitments made to participants during the informed consent process, in accordance with Turkish Personal Data Protection Law (KVKK).

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 57 non-industry observational studies under Temporomandibular Joint Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 6 months is below that.

Counting every sponsor, half of 59 studies reached it within 12 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Aug 27, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2027
CompletionEst.
May 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791173
Lead sponsor
Zeynep Serra Kalkan
Collaborators
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible party
Zeynep Serra Kalkan (Dentist, PhD Candidate, Biruni University) — Sponsor-investigator
First posted
Aug 27, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Zeynep S Kalkan, Dentist
Contact
dtzeynepserra@gmail.com
+905334651698
Esra Agaoglu, Dentist
Contact
emogul@biruni.edu.tr
+90543 433 06 06

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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