Clinical trial NCT04866849: The Effect of Bruxism on Temporomandibular Disorders
Official title: The Effect of Bruxism on Temporomandibular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism
Temporomandibular Disorder
Keywords: bruxism
Temporomandibular Disorder
Lead sponsor: Yerkoy State Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: DCTMD: AI Axis I Pain Screener
timeFrame: 0 day
measure: DCTMD: AI Axis I Symptom questionnaire
timeFrame: 0 day
measure: DCTMD: AI Axis I Clinical Examination Form
timeFrame: 0 day
Secondary outcomes:
measure: DCTMD: AI Axis II-Pain Drawing
timeFrame: 0 day
measure: DCTMD: AI Axis II-Graded Chronic Pain (version 2)
timeFrame: 0 day
measure: DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)
timeFrame: 0 day
measure: DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)
timeFrame: 0 day
measure: DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)
timeFrame: 0 day
Other outcomes:
Locations:
city: Yerköy
country: Turkey
facility: Başak Çiğdem Karaçay
state: Yozgat
Study officials:
References:
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citation: 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.
citation: 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.
citation: Lobbezoo F, Lavigne GJ. Do bruxism and temporomandibular disorders have a cause-and-effect relationship? J Orofac Pain. 1997 Winter;11(1):15-23.
citation: 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.
citation: 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.