BruxismNCT07469345
Bruxism, Pelvic Pain, Erectile Dysfunction, and Anxiety in Young Adult Men
An observational study of Bruxism and Pelvic Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Pelvic Pain, Myofascial Pain - Dysfunction Syndrome of TMJ
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2026to 15 Nov 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male 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
- 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
Who cannot join
- 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
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 Pain, Erectile Dysfunction, and Anxiety in Young Men: A Cross-Sectional Study
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.
- Conditions
- Bruxism, Pelvic Pain, Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome
- Being tested
- Questionnaire and Physical Exam
- Keywords
- chronic pelvic pain, Pelvic floor problems, Bruksizm
- Medical subject headings
- Bruxism, Pelvic Pain, Temporomandibular Joint 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 | Men who diagnosed 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
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.
Measured: 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.
Measured: 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).
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
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 posted13 Mar 2026
- Study start16 Apr 2026 (estimated)
- Primary completion16 Jul 2026 (estimated)
- Study completion15 Nov 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.
- 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
- Necmettin Erbakan University, Bilecik Seyh Edebali Universitesi
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469345
- Sponsor's protocol ID
- 28685
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: might not be shared.
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 38575267Woolf 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 20961685Fluerasu 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruxism and Pelvic Pain, Erectile Dysfunction, and Anxiety in Young Men: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07469345
- Acronym / sponsor ID
- 28685
- Conditions
- Bruxism, Pelvic Pain, Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome
- Keywords
- chronic pelvic pain, Pelvic floor problems, Bruksizm
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University, Bilecik Seyh Edebali Universitesi
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 13 Mar 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 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.
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.
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 ExamMen who diagnosed bruksizm |
| Non-bruksizm Group | – | Diagnostic Test: Questionnaire and Physical ExamControl group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male individuals aged 18-30 years Voluntary agreement to participate in the study and approval of the online informed consent form
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
Time frame: 6 months
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.
Jaw Function Assessment
Time frame: 6 months
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.
Chronic Prostatitis / Chronic Pelvic Pain Symptoms
Time frame: 6 months
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).
3 secondary outcomes
Impact of Pelvic Pain on Daily Life
Time frame: 6 months
Sexual Function Assessment
Time frame: 6 months
Anxiety Assessment
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 13 Mar 2026.
- Background: PubMed 38575267Romero-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.
- Background: PubMed 20961685Woolf 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.
- Background: PubMed 35055514Fluerasu 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.
- Individual participant dataSharing planned: Undecided. might not be shared.
Related trials for Bruxism
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
Masticatory Myofascial Pain
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
Not yet recruitingEarly Phase 1
Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis
Bruxism
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
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 Pain, 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 4 inclusion and 6 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 13 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 (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 NCT07469345, 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 13 Mar 2026.