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Clinical Trials/NCT04866849
NCT04866849
Completed
Not Applicable

The Effect of Bruxism on Temporomandibular Disorders

Yerkoy State Hospital1 site in 1 country143 target enrollmentJune 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bruxism
Sponsor
Yerkoy State Hospital
Enrollment
143
Locations
1
Primary Endpoint
DCTMD: AI Axis I Clinical Examination Form
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
August 25, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yerkoy State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Başak Çiğdem Karaçay

Spesialist

Yerkoy State Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

DCTMD: AI Axis I Clinical Examination Form

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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