NCT06052709

Brief Summary

Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 13, 2023

Last Update Submit

September 21, 2023

Conditions

BruxismOccupational Problems

Keywords

BruxismOccupational BalanceStress

Outcome Measures

Primary Outcomes (3)

  • Fonseca Anamnestic Index

    The presence and severity of temporomandibular disorders in individuals will be questioned with the Fonseca Anamnestic Index. The Fonseca Anamnestic Index consists of 10 questions. The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points), and 'Sometimes' (5 points). The questionnaire score is given points for all questions, and the severity of temporomandibular disorders is classified according to the total score: no temporomandibular disorders (0-15 points), mild temporomandibular disorders (20-40 points), moderate temporomandibular disorders (45-65 points), severe temporomandibular disorders (70-100). Turkish version, validity, and reliability study was conducted.

    up to 3 months

  • Occupational Balance Questionnaire

    Occupational Balance Questionnaire is a scale that measures self-reported occupational balance in different dimensions. The purpose of the scale is to measure the satisfaction of the individual according to the amount and variety of daily activities and to define his/her occupational balance according to the results obtained. The 11 items in the scale are scored on a 4-point scale from "strongly disagree" to "strongly agree". The total score is obtained by summing the individual items and ranges from 0 to 33, with higher scores indicating greater occupational balance. Turkish version, validity and reliability study was conducted.

    up to 3 months

  • Perceived Stress Scale

    Individuals' stress levels will be measured with the Perceived Stress Scale. The Perceived Stress Scale, consisting of 14 items, measures how stressful some situations in a person's life are perceived. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". 7 of the items containing positive statements are reverse scored-scores of the Perceived Stress Scale range from 0 to 56. A high score indicates a person's perception of stress is high. A Turkish version, validity, and reliability study of the Perceived Stress Scale was conducted.

    up to 3 months

Study Arms (2)

Individuals with bruxism

ACTIVE COMPARATOR

After the sociodemographic information of individuals is questioned, the presence and severity of temporomandibular joint disorders with the Fonseca Anamnestic Index, self-reported occupational balance with the Activity-Role Balance Questionnaire, and the individuals' stress levels with the Perceived Stress Scale will be evaluated.

Other: Occupational balance assessment

Individuals without bruxism

PLACEBO COMPARATOR

After the sociodemographic information of individuals is questioned, the presence and severity of temporomandibular joint disorders with the Fonseca Anamnestic Index, self-reported occupational balance with the Activity-Role Balance Questionnaire, and the individuals' stress levels with the Perceived Stress Scale will be evaluated.

Other: Occupational balance assessment

Interventions

Occupational balance assessmentOTHER

There is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.

Individuals with bruxismIndividuals without bruxism

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be volunteer

You may not qualify if:

  • Psychological disorders,
  • Neurological disorders,
  • Orthopedic disorders,
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Central Study Contacts

Halime ARIKAN, PhD

CONTACT

+90 546 576 51 32halimearikan92@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 25, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

TU(1)