Temporomandibular Disorders (TMD)NCT07791173
Evaluation of Temporomandibular Disorders During Pregnancy
An observational study of Temporomandibular Disorders (TMD) and Pregnancy, run by Zeynep Serra Kalkan at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Temporomandibular Disorders (TMD), Pregnancy
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Zeynep S Kalkan, Dentist, +905334651698, dtzeynepserra@gmail.com
Burcu Dincgez, Medical Doctor, +905305448828, burcu.dincgez@sbu.edu.tr
About this study
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.
- Conditions
- Temporomandibular Disorders (TMD), Pregnancy
- Keywords
- Temporomandibular Joint Disorders, Pregnancy, DC/TMD, Estrogen, Progesterone, Systemic Immune-Inflammation Index, Chronic Pain, Prospective Cohort Study
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
JFLS-8 assesses jaw-related functional limitation in mastication, mobility, and verbal/emotional expression. Higher scores indicate greater functional limitation.
Measured: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
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.
Measured: From first trimester (weeks 8-12) to third trimester (weeks 28-32
PSS-10
PSS-10 measures the degree to which situations in one's life are appraised as stressful. Higher scores indicate greater perceived stress.
Measured: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
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.
Measured: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
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.
Measured: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Serra Kalkan
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Sponsor-investigator, Zeynep Serra Kalkan, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791173
- Sponsor's protocol ID
- BIRUNI-ORT-TMJ-PREG-01
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Temporomandibular Disorders During Pregnancy
- ClinicalTrials.gov ID
- NCT07791173
- Acronym / sponsor ID
- BIRUNI-ORT-TMJ-PREG-01
- Conditions
- Temporomandibular Disorders (TMD), Pregnancy
- Keywords
- Temporomandibular Joint Disorders, Pregnancy, DC/TMD, Estrogen, Progesterone, Systemic Immune-Inflammation Index, Chronic Pain, Prospective Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zeynep Serra KalkanUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Change in Jaw Functional Limitation Scale-8 (JFLS-8) Score
Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
Change in DC/TMD Axis I Clinical Findings
Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32
PSS-10
Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
Change in Systemic Immune-Inflammation Index (SII)
Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
Change in Serum Estrogen and Progesterone Levels
Time frame: From first trimester (weeks 8-12) to third trimester (weeks 28-32)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 38493079Minervini 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Pregnancy, run by Zeynep Serra Kalkan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep S Kalkan, Dentist (+905334651698, dtzeynepserra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07791173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.