The Effect of Bruxism on Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

Official title:

The Effect of Bruxism on Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866849
• Other study ID #: 2017-KAEK-189_2021.03.10_19
• Status: Completed
• Start date: June 15, 2021
• Est. completion date: August 25, 2021

Study information

• Verified date: July 2022
• Source: Yerkoy State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 25, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Disease
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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."

Locations

Country	Name	City	State
Turkey	Basak Çigdem Karaçay	Yerköy	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Yerkoy State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View Citation

Poveda Roda R, Bagan JV, Díaz Fernández JM, Hernández Bazán S, Jiménez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCTMD: AI Axis I Pain Screener	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
Primary	DCTMD: AI Axis I Symptom questionnaire	Symptom questionnaire which assess pain characteristics as well as history of jaw noise, jaw locking, and headache.	0 day
Primary	DCTMD: AI Axis I Clinical Examination Form	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	DCTMD: AI Axis II-Pain Drawing	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
Secondary	DCTMD: AI Axis II-Graded Chronic Pain (version 2)	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
Secondary	DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)	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
Secondary	DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)	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
Secondary	DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)	Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.	0 day