- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437924
Bruxism and Pelvic Floor Dysfunction in Young Women
Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Konya, Turkey (Türkiye)
- Necmettin Erbakan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Female individuals aged 18-30 years
-Voluntary agreement to participate in the study and approval of the online informed consent form
Description
Inclusion Criteria:
- 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:
- 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).
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Bruxism Group
Women who has bruksizm
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20 mins questionnaire survey
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Non-bruksizm Group
Control group
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20 mins questionnaire survey
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bruxism Assessment Section
Time Frame: 6 months
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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.
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6 months
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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
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6 months
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Pelvic Floor Assessment Section
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Assessment Section
Time Frame: 6 months
|
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.
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Sulowska-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.
- Minguez-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Nervous System Diseases
- Muscular Diseases
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neuromuscular Diseases
- Rheumatic Diseases
- Tooth Diseases
- Pregnancy Complications
- Behavior
- Habits
- Fibromyalgia
- Bruxism
- Pelvic Floor Disorders
- Diagnostic Techniques and Procedures
- Diagnosis
- Physical Examination
Other Study ID Numbers
- 2025/721-28686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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