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The Effect of Bruxism on Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT04866849
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Başak Çiğdem Karaçay, Yerkoy State Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Bruxism Temporomandibular Disorder Other: examination

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: The Effect of Bruxism on Temporomandibular Disorders
Actual Study Start Date : June 15, 2021
Actual Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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."
 Other: examination
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
 Other: examination
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."


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866849


Locations
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Turkey
Başak Çiğdem Karaçay Recruiting
Yerköy, Yozgat, Turkey, 66900
Contact: Başak Çiğdem Karaçay    +903545162470 ext 4003    basakcigdem@hotmail.com   
Contact       basakcigdem@hotmail.com   
Principal Investigator: Başak Çiğdem Karaçay, spesialist         
Sponsors and Collaborators
Yerkoy State Hospital
More Information
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Publications:

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Responsible Party: Başak Çiğdem Karaçay, Spesialist, Yerkoy State Hospital
ClinicalTrials.gov Identifier: NCT04866849    
Other Study ID Numbers: 2017-KAEK-189_2021.03.10_19
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Başak Çiğdem Karaçay, Yerkoy State Hospital:
bruxism
Temporomandibular Disorder
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Bruxism
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
 Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Tooth Diseases