NCT07469345

Brief Summary

Bruxism is a parafunctional activity characterized by clenching or grinding of the teeth during wakefulness or sleep. Increasing evidence suggests that bruxism is not only related to orofacial structures but may also be associated with broader musculoskeletal and psychosocial conditions. Emerging literature indicates that central sensitization, stress, and anxiety may contribute to both bruxism and chronic pain conditions. However, the potential relationship between bruxism and pelvic health outcomes has not been sufficiently investigated. Pelvic pain and sexual dysfunction, including erectile dysfunction, are multifactorial conditions that may involve neuromuscular, psychological, and autonomic mechanisms. Considering the shared mechanisms related to muscle hyperactivity, stress responses, and central pain modulation, bruxism may be associated with pelvic pain symptoms and sexual dysfunction in men. Additionally, anxiety is recognized as a common contributing factor in both bruxism and pelvic floor dysfunction. The aim of this cross-sectional study is to investigate the association between bruxism, pelvic pain, erectile dysfunction, and anxiety levels in young adult men. Participants will be assessed using validated self-report questionnaires to evaluate bruxism symptoms, pelvic pain complaints, erectile function, and anxiety levels. Understanding the potential relationship between these variables may contribute to a more comprehensive biopsychosocial understanding of male pelvic health and may help guide future multidisciplinary assessment and management strategies.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Apr 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 Progress28%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

chronic pelvic painPelvic floor problemsBruksizm

Outcome Measures

Primary Outcomes (3)

  • Bruxism Assessment

    Bruxism will be assessed using self-report questions addressing both awake bruxism and sleep bruxism behaviors. Participants will report the presence and frequency of teeth clenching or grinding during wakefulness or sleep within the past six months. Pain related to bruxism will be evaluated using a Visual Analog Scale (VAS) ranging from 0 to 10, where: 0 represents no pain 10 represents the worst imaginable pain Higher scores indicate greater pain intensity associated with bruxism.

    6 months

  • Jaw Function Assessment

    Jaw functional limitations will be assessed using the Jaw Functional Limitation Scale-20 (JFLS-20). This instrument evaluates functional limitations in three domains: Mastication Jaw mobility Verbal and emotional expression Each item is scored on a 0-10 numeric rating scale, where: 0 indicates no limitation 10 indicates severe limitation The total score is calculated as the mean of the items within each domain or across all items. Higher scores indicate greater functional limitation.

    6 months

  • Chronic Prostatitis / Chronic Pelvic Pain Symptoms

    Pelvic pain symptoms will be assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The NIH-CPSI includes 9 items across three domains: Pain (0-21) Urinary symptoms (0-10) Quality of life impact (0-12) The total score ranges from 0 to 43, with higher scores indicating more severe symptoms related to chronic prostatitis or chronic pelvic pain syndrome. The validated Turkish version of the NIH-CPSI will be used (Coşkun et al., 2021).

    6 months

Secondary Outcomes (3)

  • Impact of Pelvic Pain on Daily Life

    6 months

  • Sexual Function Assessment

    6 months

  • Anxiety Assessment

    6 months

Study Arms (2)

Bruxism Group

Men who diagnosed 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
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Male participants aged 18-30 years
  • Ability to understand and complete the questionnaires
  • Voluntary participation and provision of informed consent
  • For the bruxism group: self-reported symptoms of teeth clenching or grinding during sleep or wakefulness within the past 6 months

You may not qualify if:

  • History of neurological disorders affecting motor function
  • Diagnosed psychiatric disorders requiring active treatment
  • Current use of medications that may affect sexual function
  • History of pelvic surgery
  • Known urological diseases affecting erectile function
  • Chronic systemic diseases that may influence pain perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Related Publications (3)

  • Romero-Reyes M, Bassiur JP. Temporomandibular Disorders, Bruxism and Headaches. Neurol Clin. 2024 May;42(2):573-584. doi: 10.1016/j.ncl.2023.12.010. Epub 2024 Jan 13.

    PMID: 38575267BACKGROUND
  • Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.

    PMID: 20961685BACKGROUND
  • Fluerasu MI, Bocsan IC, Tig IA, Iacob SM, Popa D, Buduru S. The Epidemiology of Bruxism in Relation to Psychological Factors. Int J Environ Res Public Health. 2022 Jan 8;19(2):691. doi: 10.3390/ijerph19020691.

    PMID: 35055514BACKGROUND

MeSH Terms

Conditions

BruxismPelvic PainTemporomandibular Joint DisordersFibromyalgia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular 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

March 10, 2026

First Posted

March 13, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

July 16, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations