- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866849
The Effect of Bruxism on Temporomandibular Disorders
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yozgat
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Yerköy, Yozgat, Turkey, 66900
- Basak Cigdem karacay
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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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
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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
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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.
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0 day
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DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)
Time Frame: 0 day
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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
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0 day
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DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)
Time Frame: 0 day
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Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.
|
0 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Goldstein RE, Auclair Clark W. The clinical management of awake bruxism. J Am Dent Assoc. 2017 Jun;148(6):387-391. doi: 10.1016/j.adaj.2017.03.005.
- Poveda Roda R, Bagan JV, Diaz Fernandez JM, Hernandez Bazan S, Jimenez Soriano Y. Review of temporomandibular joint pathology. Part I: classification, epidemiology and risk factors. Med Oral Patol Oral Cir Bucal. 2007 Aug 1;12(4):E292-8.
- Manfredini D, Lobbezoo F. Relationship between bruxism and temporomandibular disorders: a systematic review of literature from 1998 to 2008. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jun;109(6):e26-50. doi: 10.1016/j.tripleo.2010.02.013.
- Lobbezoo F, Lavigne GJ. Do bruxism and temporomandibular disorders have a cause-and-effect relationship? J Orofac Pain. 1997 Winter;11(1):15-23.
- Nakata A, Takahashi M, Ikeda T, Hojou M, Araki S. Perceived psychosocial job stress and sleep bruxism among male and female workers. Community Dent Oral Epidemiol. 2008 Jun;36(3):201-9. doi: 10.1111/j.1600-0528.2007.00388.x.
- Guo H, Wang T, Niu X, Wang H, Yang W, Qiu J, Yang L. The risk factors related to bruxism in children: A systematic review and meta-analysis. Arch Oral Biol. 2018 Feb;86:18-34. doi: 10.1016/j.archoralbio.2017.11.004. Epub 2017 Nov 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-KAEK-189_2021.03.10_19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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