NCT04866849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

16 days

First QC Date

April 26, 2021

Last Update Submit

July 11, 2022

Conditions

Keywords

bruxismTemporomandibular Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • DCTMD: AI Axis II-Pain Drawing

    0 day

  • DCTMD: AI Axis II-Graded Chronic Pain (version 2)

    0 day

  • DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)

    0 day

  • DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)

    0 day

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

    0 day

Study Arms (2)

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

CONTROL GROUP

healthy volunteers

Other: examination

Interventions

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 GROUPSTUDY GROUP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Sixty patients diagnosed with bruxism according to self-reported bruxism and examination.
  • Sixty healthy volunteers

You may not qualify if:

  • Patients with temporomandibular region surgery
  • Congenital teporomandibular joint pathologies
  • Previous temporomandibular region trauma were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başak Çiğdem Karaçay

Yerköy, Yozgat, 66900, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 28550845BACKGROUND
  • 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.

    PMID: 17664915BACKGROUND
  • 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.

    PMID: 20451831BACKGROUND
  • Lobbezoo F, Lavigne GJ. Do bruxism and temporomandibular disorders have a cause-and-effect relationship? J Orofac Pain. 1997 Winter;11(1):15-23.

    PMID: 10332307BACKGROUND
  • 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.

    PMID: 18474052BACKGROUND
  • 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.

    PMID: 29149621BACKGROUND
  • Cigdem Karacay B, Sahbaz T. Investigation of the relationship between probable sleep bruxism, awake bruxism and temporomandibular disorders using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Dent Med Probl. 2023 Oct-Dec;60(4):601-608. doi: 10.17219/dmp/158926.

MeSH Terms

Conditions

BruxismTemporomandibular Joint Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Spesialist

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 30, 2021

Study Start

June 15, 2021

Primary Completion

July 1, 2021

Study Completion

August 25, 2021

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations