ClinicalTrials.gg
Enrolling by invitationNCT07469345Updated Mar 13, 2026

Bruxism, Pelvic Pain, Erectile Dysfunction, and Anxiety in Young Adult Men

An observational study in Bruxism, Pelvic Pain and Myofascial Pain - Dysfunction Syndrome of TMJ, sponsored by Akdeniz University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Akdeniz University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 30 Years
Sex
Male
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Study 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.

Read the detailed description

Bruxism has been linked with stress, anxiety, autonomic nervous system dysregulation, and central sensitization processes. These mechanisms may also play a role in the development and maintenance of chronic pain conditions beyond the orofacial region.

Pelvic pain and sexual dysfunction in men, including erectile dysfunction, are complex conditions with multifactorial etiologies involving musculoskeletal, neurological, vascular, and psychosocial factors. Increasing evidence suggests that pelvic floor muscle overactivity, stress-related autonomic responses, and psychological distress may contribute to pelvic pain syndromes and sexual dysfunction. Anxiety, in particular, has been identified as an important factor influencing both pelvic floor muscle tension and erectile function.

Given that bruxism is associated with muscle hyperactivity, stress responses, and psychological factors, it is plausible that individuals with bruxism may also experience symptoms related to pelvic floor dysfunction. However, the potential relationship between bruxism and male pelvic health outcomes, such as pelvic pain and erectile dysfunction, has not been sufficiently investigated in the literature. Understanding whether bruxism is associated with pelvic symptoms may provide insight into shared neuromuscular or biopsychosocial mechanisms.

The primary aim of this cross-sectional study is to investigate the association between bruxism and pelvic pain in young adult men. Secondary aims include examining the relationship between bruxism and erectile dysfunction as well as anxiety levels. Participants will be young adult men recruited from the general population. Bruxism status will be assessed using validated self-report measures consistent with current international consensus definitions of probable bruxism. Pelvic pain symptoms, erectile function, and anxiety levels will be evaluated using validated questionnaires.

Statistical analyses will be conducted to examine the relationships between bruxism and pelvic pain, erectile dysfunction, and anxiety. Correlation and group comparison analyses will be used to explore potential associations between these variables. The findings of this study may contribute to a broader understanding of the relationship between orofacial parafunctional activities and pelvic health outcomes. Identifying potential links between bruxism and pelvic floor-related symptoms may help support a multidisciplinary perspective in the assessment and management of men presenting with pelvic pain or sexual dysfunction.

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Conditions studied

  • Bruxism
  • Pelvic Pain
  • Myofascial Pain - Dysfunction Syndrome of TMJ
  • Myofascial Pain Dysfunction Syndrome

Keywords

  • chronic pelvic pain
  • Pelvic floor problems
  • Bruksizm
03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's planned enrollment of 100 is above the median of 89 across 55 observational studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Akdeniz University is the lead sponsor of 297 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Male individuals aged 18-30 years

Voluntary agreement to participate in the study and approval of the online informed consent form

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male participants aged 18-30 years

Ability to understand and complete the questionnaires

Voluntary participation and provision of

For the bruxism group: self-reported symptoms of teeth clenching or grinding during sleep or wakefulness within the past 6 months

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
50 Months
Patient registry
Yes

Groups and cohorts

  • Bruxism Group

    Men who diagnosed bruksizm

    Diagnostic Test: Questionnaire and Physical Exam

  • Non-bruksizm Group

    Control group

    Diagnostic Test: Questionnaire and Physical Exam

Interventions

  • Diagnostic testQuestionnaire and Physical Exam

    20 mins questionnaire survey

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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).

    Time frame: 6 months

Secondary outcomes

  1. Impact of Pelvic Pain on Daily Life

    The impact of pelvic pain on daily functioning and quality of life will be assessed using the Male Pelvic Pain Impact Questionnaire. This questionnaire evaluates how pelvic pain affects daily activities, social participation, and emotional well-being. Higher scores indicate greater negative impact of pelvic pain on daily life.

    Time frame: 6 months

  2. Sexual Function Assessment

    Sexual function will be assessed using questions derived from the International Index of Erectile Function (IIEF) focusing on erectile function during the previous four weeks. The erectile function domain score ranges from 1 to 30, with interpretation as follows: 26-30: normal erectile function 22-25: mild erectile dysfunction 17-21: mild to moderate erectile dysfunction 11-16: moderate erectile dysfunction ≤10: severe erectile dysfunction Higher scores indicate better erectile function.

    Time frame: 6 months

  3. Anxiety Assessment

    Anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI), which includes two subscales: STAI-State (STAI-S): measures current anxiety level STAI-Trait (STAI-T): measures general anxiety tendency Each subscale consists of 20 items, scored on a 4-point Likert scale. Possible scores range from 20 to 80, where: 20-37: low anxiety 38-44: moderate anxiety 45-80: high anxiety Higher scores indicate higher levels of anxiety.

    Time frame: 6 months

07

Study locations

1 site
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References and documents

Publications

  • 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. PubMed 38575267 ↗
  • 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. PubMed 20961685 ↗
  • 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. PubMed 35055514 ↗

Individual participant data

Plan to share: Undecided — might not be shared.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Jul 2026, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2026
First posted
Mar 13, 2026
StartEst.
Apr 16, 2026
Primary completionEst.
Jul 16, 2026
CompletionEst.
Nov 15, 2026
Last update
Mar 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07469345
Lead sponsor
Akdeniz University
Collaborators
Necmettin Erbakan University, Bilecik Seyh Edebali Universitesi
Responsible party
Alime Buyuk (PhD,Akdeniz University, Physiotherapy and Rehabilitation Department, Akdeniz University) — Principal investigator
First posted
Mar 13, 2026
Start date
Apr 16, 2026 (estimated)
Primary completion
Jul 16, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Mar 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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