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临床试验/NCT07437924
NCT07437924Enrolling By Invitation不适用

Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms

Akdeniz University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Bruxism Assessment Section

研究概览

简要总结

Bruxism and Pelvic Floor Dysfunction in Young Women

详细描述

Bruxism and Pelvic Floor Dysfunction in Young Women: A Cross-Sectional Questionnaire Study Examining the Relationship Between Orofacial Parafunction and Pelvic Floor Symptoms

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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)

研究组 & 干预措施

Bruxism Group

Women who has bruksizm

干预措施: Questionnaire and Physical Exam (Diagnostic Test)

Non-bruksizm Group

Control group

干预措施: Questionnaire and Physical Exam (Diagnostic Test)

结局指标

主要结局

Bruxism Assessment Section

时间窗: 6 months

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.

Jaw Function Assessment Section

时间窗: 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

Pelvic Floor Assessment Section

时间窗: 6 months

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

次要结局

  • Anxiety Assessment Section(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alime Buyuk

PhD,Akdeniz University, Physiotherapy and Rehabilitation Department

Akdeniz University

研究点 (1)

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