Temporomandibular Disorders (TMD)NCT06760884
Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women
An observational study of Temporomandibular Disorders (TMD) and Pregnancy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD), Pregnancy
- How many people
- 224 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to 30 Jun 2025
- How long will I take part?
- 1 Day
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The universe of the study consists of women who apply to the pregnancy clinic. In parallel, a control group of 112 healthy non-pregnant women (similar to the pregnant group in terms of age, height, weight, education level, etc. to ensure homogeneity) will be created.
Who may be able to join
- Being between the ages of 18-45,
- At least primary school graduate,
- Able to speak and understand Turkish,
- Women diagnosed with pregnancy by USG,
- Singleton pregnancy,
- Agreeing to participate in the study voluntarily.
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- Being between the ages of 18-45,
- At least primary school graduate,
- Able to speak and understand Turkish,
- Agreeing to participate in the study voluntarily.
Who cannot join
- Those with any systemic disease concerning the musculoskeletal system,
- Women with any type of disability,
- Having communication problems,
- Multiple pregnancy,
- Refusing to participate in the study.
- Those with any systemic disease concerning the musculoskeletal system,
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- Women with any type of disability,
- Having communication problems,
- Refusing to participate in the study.
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, 1 recruiting
- Recruiting
Karadeniz Technical Univerity
Trabzon
Nurhayat Korkmaz, Msc, +905387369062, krkmznrhyt@gmail.com
About this study
Official title: Determination of Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women: a Cross-Sectional Case-Control Study
The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .
Read the detailed description
When looking at the literature, it is seen that physiological and hormonal changes that occur in pregnant women affect the musculoskeletal system and pain threshold of women. These changes seen in pregnant women and their psychological levels throughout the process also contribute negatively to the process.Due to the insufficiency of studies examining temporomandibular joint (TMJ) problems and oral habits in pregnant women and the contradictory results in existing studies, it is seen that new studies are needed.
- Conditions
- Temporomandibular Disorders (TMD), Pregnancy
- Keywords
- temporomandibular disorders, pregnancy, oral habits, pain
- Medical subject headings
- Temporomandibular Joint Disorders, 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 |
|---|---|---|
| Study group | Pregnancy women | |
| Control group | Non-Pregnancy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular disorders function
Fonseca Anamnestic Index, which is reported as a reliable and valid index, will be used to evaluate the presence/absence of temporomandibular disorder and the severity of the disorder.
Measured: 1 year
Mandibular function
The Mandibular Function Impairment Questionnaire (MFBA), a questionnaire that evaluates jaw function impairment with different sub-dimensions, will also be used.
Measured: 1 year
Secondary outcomes (2)
Oral Habits
The Oral Habits Checklist will be used.
Measured: 1 year
Pain assessment
The presence, frequency and duration (how long has it been present) and severity of jaw, neck, back and waist pain will be questioned. The severity of pain will be assessed using the Numerical Pain Scale. This scale rates pain from "0" ("no pain") to "10" ("worst pain imaginable")
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start2 Dec 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 224 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhayat KORKMAZ, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760884
- Sponsor's protocol ID
- KTU-FTR-2024/123
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women: a Cross-Sectional Case-Control Study
- ClinicalTrials.gov ID
- NCT06760884
- Acronym / sponsor ID
- KTU-FTR-2024/123
- Conditions
- Temporomandibular Disorders (TMD), Pregnancy
- Keywords
- temporomandibular disorders, pregnancy, oral habits, pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .
Detailed description
When looking at the literature, it is seen that physiological and hormonal changes that occur in pregnant women affect the musculoskeletal system and pain threshold of women. These changes seen in pregnant women and their psychological levels throughout the process also contribute negatively to the process.Due to the insufficiency of studies examining temporomandibular joint (TMJ) problems and oral habits in pregnant women and the contradictory results in existing studies, it is seen that new studies are needed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Pregnancy women |
| Control group | – | –Non-Pregnancy women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The universe of the study consists of women who apply to the pregnancy clinic. In parallel, a control group of 112 healthy non-pregnant women (similar to the pregnant group in terms of age, height, weight, education level, etc. to ensure homogeneity) will be created.
Key inclusion criteria (10 listed)
- Being between the ages of 18-45,
- At least primary school graduate,
- Able to speak and understand Turkish,
- Women diagnosed with pregnancy by USG,
- Singleton pregnancy,
Key exclusion criteria (9 listed)
- Those with any systemic disease concerning the musculoskeletal system,
- Women with any type of disability,
- Having communication problems,
- Multiple pregnancy,
- Refusing to participate in the study.
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
Temporomandibular disorders function
Time frame: 1 year
Fonseca Anamnestic Index, which is reported as a reliable and valid index, will be used to evaluate the presence/absence of temporomandibular disorder and the severity of the disorder.
Mandibular function
Time frame: 1 year
The Mandibular Function Impairment Questionnaire (MFBA), a questionnaire that evaluates jaw function impairment with different sub-dimensions, will also be used.
2 secondary outcomes
Oral Habits
Time frame: 1 year
Pain assessment
Time frame: 1 year
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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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 Karadeniz Technical University 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. 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 Nurhayat Korkmaz, MSc (+905387369062, krkmznrhyt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular disorders function (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.