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Completed

NCT Number: NCT04866849

The Effect of Bruxism on Temporomandibular Disorders

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.

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Key information

Conditions

Bruxism Behavior Craniomandibular Disorders Habits Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Disorder Temporomandibular Joint Disorders Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Başak Çiğdem Karaçay

Yerköy, Yozgat, 66900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Examination

Other

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."

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)

    Time frame: 0 day

    Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.

Sponsors and collaborators

Lead sponsor

Yerkoy State Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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