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临床试验/NCT04866849
NCT04866849已完成不适用

The Effect of Bruxism on Temporomandibular Disorders

Yerkoy State Hospital1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
1
主要终点
DCTMD: AI Axis I Clinical Examination Form

研究概览

简要总结

This case-control study consists of 120 participants aged between 18 and 65 years. Case group included 60 patients with bruxism who presented to physical medicine and rehabilitation outpatient clinic between May 2021 and August 2021. Control group included 60 healthy participant. Patients who had temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were also excluded. Assessments including age, gender, body mass index (BMI), education level, and symptom duration were recorded. Patients was evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments. Patients was evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4) , Oral Behaviors Checklist were applied within the scope of Axis II.

详细描述

The aim of this study was to effect of bruxism on temporomandibular disorders (TMD) diagnosed by means of the research diagnostic criteria for temporomandibular disorders (RDC/TMD).

This case-control study consists of 120 participants aged between 18 and 65 years. Case group will be included 60 patients with bruxism who presented to physical medicine and rehabilitation outpatient clinic between May 2021 and August 2021. Control group will be included 60 healthy participant. Patients who had temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were also excluded.

Assessments including age, gender, body mass index (BMI), education level, and symptom duration will be recorded. Patients will evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments. Patients was evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4) , Oral Behaviors Checklist will applied within the scope of Axis II.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sixty patients diagnosed with bruxism according to self-reported bruxism and examination.
  • Sixty healthy volunteers

排除标准

  • Patients with temporomandibular region surgery
  • Congenital teporomandibular joint pathologies
  • Previous temporomandibular region trauma were excluded from the study.

结局指标

主要结局

DCTMD: AI Axis I Clinical Examination Form

时间窗: 0 day

Clinical Examination Form- The clinical examination includes provocation tests for TMJ arthralgia of pain with any jaw movement (ie, opening, lateral, and protrusive) and TMJ palpation. For myalgia, the tests include pain with opening jaw movements and palpation of the temporalis and masseter muscles.

DCTMD: AI Axis I Symptom questionnaire

时间窗: 0 day

Symptom questionnaire which assess pain characteristics as well as history of jaw noise, jaw locking, and headache.

DCTMD: AI Axis I Pain Screener

时间窗: 0 day

MD Pain Screener which is a simple, reliable, and valid self-report instrument used to assess for the presence of any pain-related TMD, with sensitivity and specificity ≥ 0.95 which is recommended for all patients in any clinical setting. A positive screen is followed by further evaluation to arrive at the specific TMD pain-related diagnoses.

次要结局

  • DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)(0 day)
  • DCTMD: AI Axis II-Graded Chronic Pain (version 2)(0 day)
  • DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)(0 day)
  • DCTMD: AI Axis II-Pain Drawing(0 day)
  • DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)(0 day)

研究者

发起方
Yerkoy State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Başak Çiğdem Karaçay

Spesialist

Yerkoy State Hospital

研究点 (1)

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