BruxismNCT07437924
Bruxism and Pelvic Floor Dysfunction in Young Women
An observational study of Bruxism and Pelvic Floor Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Bruxism and Pelvic Floor Dysfunction in Young Women Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Pelvic Floor Disorder, Young Adult Females
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 15 May 2026
- How long will I take part?
- 50 Months
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female individuals aged 18-30 years -Voluntary agreement to participate in the study and approval of the online informed consent form
Who may be able to join
- Female individuals aged 18-30 years
- Voluntary agreement to participate in the study and approval of the online informed consent form
- For the bruxism group:
- Self-reported teeth clenching and/or grinding behavior during wakefulness or sleep within the past 6 months
- Presence of clinical findings supporting bruxism (e.g., tooth wear patterns, masseter/temporalis muscle tenderness) identified during a clinical examination conducted at the Faculty of Dentistry
- For the non-bruxism group:
Show all 9Show fewer
- No self-reported teeth clenching or grinding behavior
- Absence of clinical findings supporting bruxism upon examination
- Bruxism classification will be performed in accordance with the current international consensus, based on self-report combined with clinical findings, within the framework of "probable bruxism" (Verhoeff et al., 2025).
Who cannot join
- Diagnosed temporomandibular joint (TMJ) dysfunction or significant jaw pain syndromes
- History of major pelvic surgery; early postpartum period (<1 year) or current pregnancy
- Neurological disorders (e.g., multiple sclerosis, peripheral neuropathies)
- Presence of active urogenital or colorectal infection/disease
- Diagnosed pelvic floor pathologies (e.g., advanced pelvic organ prolapse, severe urinary/fecal incontinence)
- Chronic use of opioids, anticholinergic agents, or muscle relaxants
- Severe psychiatric disorders (e.g., diagnosed major depressive disorder, generalized anxiety disorder)
- Receipt of any bruxism-related treatment within the past 6 months (e.g., occlusal splint therapy, botulinum toxin injections, intensive physiotherapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms
Bruxism and Pelvic Floor Dysfunction in Young Women
Read the detailed description
Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms
- Conditions
- Bruxism, Pelvic Floor Disorder, Young Adult Females, Myofascial Pain Dysfunction Syndrome, TMJ Pain
- Being tested
- Questionnaire and Physical Exam
- Keywords
- bruxism, pelvic floor dysfuctions, myofascial problems
- Medical subject headings
- Bruxism, Pelvic Floor Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic test
20 mins questionnaire survey
| Study group | Role | What they receive |
|---|---|---|
| Bruxism Group | Women who has bruksizm Receives: Diagnostic Test: Questionnaire and Physical Exam | |
| Non-bruksizm Group | Control group Receives: Diagnostic Test: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruxism Assessment Section
Sleep and awake bruxism will be evaluated according to the bruxism diagnostic criteria established by the American Academy of Sleep Medicine (AASM) in 2023. Bruxism-related pain will be subjectively assessed using the Visual Analog Scale (VAS). The Visual Analogue Scale (VAS) is a 10-cm used to measure pain intensity, where 0 represents "no pain" and 10 represents the "worst imaginable pain. Patients mark their pain level, which is measured in cm or mm to determine the score.
Measured: 6 months
Jaw Function Assessment Section
Jaw function will be evaluated using the Jaw Functional Limitation Scale-20 (JFLS-20). The Jaw Functional Limitation Scale-20 (JFLS-20) scores range from 0 to 200 (or 0-10 average per item), with higher scores indicating more severe jaw functional limitation. It measures 20 items across three constructs-mastication, vertical mobility, and verbal/emotional expression-using a 0-10 scale, with 0 meaning "no limitation" and 10 meaning "severe limitation
Measured: 6 months
Pelvic Floor Assessment Section
Pelvic floor symptoms will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and the relevant items of the Pelvic Pain Impact Questionnaire. The Pelvic Floor Distress Inventory-20 (PFDI-20) is a questionnaire measuring the severity of pelvic floor dysfunction, with total scores ranging from 0 to 300 (0 = no distress, 300 = maximum distress). It includes three subscales-POPDI-6, UDI-6, and CRADI-8-each scored from 0 to 100, calculated by multiplying the mean of answered items (0-4) by 25
Measured: 6 months
Secondary outcomes (1)
Anxiety Assessment Section
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI - State Anxiety Scale). The State-Trait Anxiety Inventory (STAI-S) assesses temporary, immediate, or situation-specific anxiety using a 20-item self-report questionnaire with 4-point Likert-type responses. Scores range from 20 to 80, with higher scores indicating higher levels of anxiety. A cutoff of 39-40 is often used for detecting clinically significant symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start16 Feb 2026
- Primary completion16 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 50 Months
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Konya Necmettin Erbakan Üniversitesi, Bilecik Seyh Edebali Universitesi
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437924
- Sponsor's protocol ID
- 2025/721-28686
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verhoeff MC, Lobbezoo F, Ahlberg J, Bender S, Bracci A, Colonna A, Dal Fabbro C, Durham J, Glaros AG, Haggman-Henrikson B, Kato T, Koutris M, Lavigne GJ, Nykanen L, Raphael KG, Svensson P, Wieckiewicz M, Manfredini D. Updating the Bruxism Definitions: Report of an International Consensus Meeting. J Oral Rehabil. 2025 Sep;52(9):1335-1342. doi: 10.1111/joor.13985. Epub 2025 May 1.
PubMed 40312776Sulowska-Daszyk I, Gamrot S, Handzlik-Waszkiewicz P. A Single Session of Temporomandibular Joint Soft Tissue Therapy and Its Effect on Pelvic Floor Muscles Activity in Women-A Randomized Controlled Trial. J Clin Med. 2024 Nov 21;13(23):7037. doi: 10.3390/jcm13237037.
PubMed 39685496Minguez-Esteban I, De-la-Cueva-Reguera M, Romero-Morales C, Martinez-Pascual B, Navia JA, Bravo-Aguilar M, Abuin-Porras V. Physical manifestations of stress in women. Correlations between temporomandibular and pelvic floor disorders. PLoS One. 2024 Apr 16;19(4):e0296652. doi: 10.1371/journal.pone.0296652. eCollection 2024.
PubMed 38626037
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms
- ClinicalTrials.gov ID
- NCT07437924
- Acronym / sponsor ID
- 2025/721-28686
- Conditions
- Bruxism, Pelvic Floor Disorder, Young Adult Females, Myofascial Pain Dysfunction Syndrome, TMJ Pain
- Keywords
- bruxism, pelvic floor dysfuctions, myofascial problems
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Konya Necmettin Erbakan Üniversitesi, Bilecik Seyh Edebali Universitesi
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 27 Feb 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.
Bruxism and Pelvic Floor Dysfunction in Young Women
Detailed description
Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 50 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism Group | – | Diagnostic Test: Questionnaire and Physical ExamWomen who has bruksizm |
| Non-bruksizm Group | – | Diagnostic Test: Questionnaire and Physical ExamControl group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female individuals aged 18-30 years -Voluntary agreement to participate in the study and approval of the online informed consent form
Key inclusion criteria (9 listed)
- Female individuals aged 18-30 years
- Voluntary agreement to participate in the study and approval of the online informed consent form
- Self-reported teeth clenching and/or grinding behavior during wakefulness or sleep within the past 6 months
- Presence of clinical findings supporting bruxism (e.g., tooth wear patterns, masseter/temporalis muscle tenderness) identified during a clinical examination conducted at the Faculty of Dentistry
- No self-reported teeth clenching or grinding behavior
Key exclusion criteria (8 listed)
- Diagnosed temporomandibular joint (TMJ) dysfunction or significant jaw pain syndromes
- History of major pelvic surgery; early postpartum period (<1 year) or current pregnancy
- Neurological disorders (e.g., multiple sclerosis, peripheral neuropathies)
- Presence of active urogenital or colorectal infection/disease
- Diagnosed pelvic floor pathologies (e.g., advanced pelvic organ prolapse, severe urinary/fecal incontinence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical Exam20 mins questionnaire survey | Diagnostic test | Bruxism Group, Non-bruksizm Group |
Primary outcome
Bruxism Assessment Section
Time frame: 6 months
Sleep and awake bruxism will be evaluated according to the bruxism diagnostic criteria established by the American Academy of Sleep Medicine (AASM) in 2023. Bruxism-related pain will be subjectively assessed using the Visual Analog Scale (VAS). The Visual Analogue Scale (VAS) is a 10-cm used to measure pain intensity, where 0 represents "no pain" and 10 represents the "worst imaginable pain. Patients mark their pain level, which is measured in cm or mm to determine the score.
Jaw Function Assessment Section
Time frame: 6 months
Jaw function will be evaluated using the Jaw Functional Limitation Scale-20 (JFLS-20). The Jaw Functional Limitation Scale-20 (JFLS-20) scores range from 0 to 200 (or 0-10 average per item), with higher scores indicating more severe jaw functional limitation. It measures 20 items across three constructs-mastication, vertical mobility, and verbal/emotional expression-using a 0-10 scale, with 0 meaning "no limitation" and 10 meaning "severe limitation
Pelvic Floor Assessment Section
Time frame: 6 months
Pelvic floor symptoms will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and the relevant items of the Pelvic Pain Impact Questionnaire. The Pelvic Floor Distress Inventory-20 (PFDI-20) is a questionnaire measuring the severity of pelvic floor dysfunction, with total scores ranging from 0 to 300 (0 = no distress, 300 = maximum distress). It includes three subscales-POPDI-6, UDI-6, and CRADI-8-each scored from 0 to 100, calculated by multiplying the mean of answered items (0-4) by 25
1 secondary outcome
Anxiety Assessment Section
Time frame: 6 months
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 12 Mar 2026.
- Background: PubMed 40312776Verhoeff MC, Lobbezoo F, Ahlberg J, Bender S, Bracci A, Colonna A, Dal Fabbro C, Durham J, Glaros AG, Haggman-Henrikson B, Kato T, Koutris M, Lavigne GJ, Nykanen L, Raphael KG, Svensson P, Wieckiewicz M, Manfredini D. Updating the Bruxism Definitions: Report of an International Consensus Meeting. J Oral Rehabil. 2025 Sep;52(9):1335-1342. doi: 10.1111/joor.13985. Epub 2025 May 1.
- Background: PubMed 39685496Sulowska-Daszyk I, Gamrot S, Handzlik-Waszkiewicz P. A Single Session of Temporomandibular Joint Soft Tissue Therapy and Its Effect on Pelvic Floor Muscles Activity in Women-A Randomized Controlled Trial. J Clin Med. 2024 Nov 21;13(23):7037. doi: 10.3390/jcm13237037.
- Background: PubMed 38626037Minguez-Esteban I, De-la-Cueva-Reguera M, Romero-Morales C, Martinez-Pascual B, Navia JA, Bravo-Aguilar M, Abuin-Porras V. Physical manifestations of stress in women. Correlations between temporomandibular and pelvic floor disorders. PLoS One. 2024 Apr 16;19(4):e0296652. doi: 10.1371/journal.pone.0296652. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bruxism and Pelvic Floor Disorder, run by Akdeniz 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 9 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruxism Assessment Section (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT07437924, which also lists 3 linked publications.
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 12 Mar 2026.