The Effect of Bruxism on Temporomandibular Disorders

July 11, 2022 updated by: Başak Çiğdem Karaçay, Yerkoy State Hospital
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yozgat
      • Yerköy, Yozgat, Turkey, 66900
        • Basak Cigdem karacay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STUDY GROUP
patient diagnosed with bruxism The presence of bruxism was based on self-reported bruxism and examination. Self reported bruxism was recorded as "yes" or "no" . Participants were examined for the existence of four clinical signs of bruxism: (I) abnormal tooth wear, (II) impressions of teeth in the buccal area, (III) impressions of teeth on the tongue, and (IV) hypertrophy of the masseter muscle. In this study, clinical signs of bruxism were considered present if one of the four items was answered "yes."
The presence of bruxism was based on self-reported bruxism and examination. Self reported bruxism was recorded as "yes" or "no" . Participants were examined for the existence of four clinical signs of bruxism: (I) abnormal tooth wear, (II) impressions of teeth in the buccal area, (III) impressions of teeth on the tongue, and (IV) hypertrophy of the masseter muscle. In this study, clinical signs of bruxism were considered present if one of the four items was answered "yes."
CONTROL GROUP
healthy volunteers
The presence of bruxism was based on self-reported bruxism and examination. Self reported bruxism was recorded as "yes" or "no" . Participants were examined for the existence of four clinical signs of bruxism: (I) abnormal tooth wear, (II) impressions of teeth in the buccal area, (III) impressions of teeth on the tongue, and (IV) hypertrophy of the masseter muscle. In this study, clinical signs of bruxism were considered present if one of the four items was answered "yes."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 day
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.
0 day
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.
0 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCTMD: AI Axis II-Pain Drawing
Time Frame: 0 day
Pain Drawing-pain drawing of the head, jaw, and body, and it allows the patient to report the location of all pain complaints
0 day
DCTMD: AI Axis II-Graded Chronic Pain (version 2)
Time Frame: 0 day
Graded Chronic Pain (version 2) is a short, reliable, and valid instrument that assesses pain intensity and pain-related disability.10 The two GCPS subscales are: Characteristic Pain Intensity (CPI), which reliably measures pain intensity, with ≥ 50/100 considered "high intensity," and the pain-disability rating, which is based on number of days that pain interferes with activity and on extent of interference with social, work, or usual daily activities
0 day
DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)
Time Frame: 0 day
Jaw Functional Limitation Scale-8 (JFLS-8) which assesses global limitations across mastication, jaw mobility, and verbal and emotional expressionJFLS-8 is aimed to evaluate functional limitation of the jaw. The restriction due to TMD is indicated in eight items and these include changes in jaw mobility (item four), mastication (items 1-3), and verbal and emotional expression (items 5-8).Patient will asked to score between 0 and 10 according to the severity of the restriction. A higher score indicates more functional limitations.
0 day
DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)
Time Frame: 0 day
Patient Health Questionnaire (PHQ-4) is a short, reliable, and valid screening instrument for detecting "psychological distress" due to anxiety and/or depression in patients in any clinical setting.A cutoff of > 6, suggesting moderate psychological stress, should be interpreted as warranting observation, while a cutoff of > 9, suggesting severe psychological distress, should be interpreted as warranting either further assessment or referral
0 day
DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)
Time Frame: 0 day
Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.
0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 25, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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