NCT07437924

Brief Summary

Bruxism and Pelvic Floor Dysfunction in Young Women

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 23, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

bruxismpelvic floor dysfuctionsmyofascial problems

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    6 months

Secondary Outcomes (1)

  • Anxiety Assessment Section

    6 months

Study Arms (2)

Bruxism Group

Women who has bruksizm

Diagnostic Test: Questionnaire and Physical Exam

Non-bruksizm Group

Control group

Diagnostic Test: Questionnaire and Physical Exam

Interventions

20 mins questionnaire survey

Bruxism GroupNon-bruksizm Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female individuals aged 18-30 years -Voluntary agreement to participate in the study and approval of the online informed consent form

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 40312776BACKGROUND
  • 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.

    PMID: 39685496BACKGROUND
  • 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.

    PMID: 38626037BACKGROUND

MeSH Terms

Conditions

BruxismPelvic Floor DisordersFibromyalgia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
50 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,Akdeniz University, Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

February 16, 2026

Primary Completion

April 16, 2026

Study Completion

May 15, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

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