NCT04396171

Brief Summary

This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus and assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 16, 2020

Last Update Submit

May 16, 2020

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

  • probable bruxism

    Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism. For this purpose clinical inspection, one of the non-instrumental approaches, was used to evaluate the clinical features of bruxism. Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.

    5 minutes

Study Arms (2)

Probable bruxism(+)

Probable bruxism(-)

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who applied to Department of Periodontology, Baskent University were included into the study.

You may qualify if:

  • Patients with 18 years and older

You may not qualify if:

  • age under 18 years,
  • edentulous patients,
  • not interested to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University,Department of Dentistry

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mehtap Bilgin Çetin

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 20, 2020

Study Start

March 10, 2019

Primary Completion

January 20, 2020

Study Completion

February 10, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations

TU(1)