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Investigation of Occupational Balance in Individuals With and Without Bruxism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06052709
Recruitment Status : Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Halime Arikan, Tokat Gaziosmanpasa University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bruxism Occupational Problems Other: Occupational balance assessment Not Applicable

Detailed Description:

Occupation refers to daily life activities and task groups that are named, organized, given value and meaning by individuals and a culture. Occupation is everything people do to keep themselves busy, including taking care of themselves, enjoying life, and contributing to the social and economic fabric of their communities.

Bruxism is a parafunctional habit among temporomandibular disorders that occurs as a result of clenching and grinding teeth and overloading the stomatognathic structures. At the same time, bruxism is the chewing movement of the mandible, characterized by involuntary, rhythmic and non-functional teeth clenching and grinding, usually seen during sleep, and manifested by severe head and neck pain, limitation in jaw movements, pain and spasm in the chewing muscles. Although its etiology cannot be fully explained, it is thought that factors such as stress, occlusal disorders, allergies and sleep quality may be the source.

The deterioration or decrease in occupational balance may also be associated with people's quality of life. Occupational imbalance is reported to affect both physical and psychological state, creating significant stress on the body and mind, causing mental health problems and burnout.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Investigation of Occupational Balance in Individuals With and Without Bruxism
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Individuals with bruxism
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
There is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.
Placebo Comparator: Individuals without bruxism
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
There is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.


Outcome Measures
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Primary Outcome Measures :
  1. Fonseca Anamnestic Index [ Time Frame: up to 3 months ]
    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.

  2. Occupational Balance Questionnaire [ Time Frame: up to 3 months ]
    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.

  3. Perceived Stress Scale [ Time Frame: up to 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be volunteer

Exclusion Criteria:

  • Psychological disorders,
  • Neurological disorders,
  • Orthopedic disorders,
  • Cognitive impairment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052709


Contacts
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Contact: Halime ARIKAN, PhD +90 546 576 51 32 halimearikan92@gmail.com

Locations
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Turkey
Tokat Gaziosmanpasa University
Tokat, Turkey, 60250
Contact: Halime ARIKAN, PhD    +90 546 576 51 32    halimearikan92@gmail.com   
Sponsors and Collaborators
Tokat Gaziosmanpasa University
More Information
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Responsible Party: Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT06052709    
Other Study ID Numbers: 13.20
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halime Arikan, Tokat Gaziosmanpasa University:
Bruxism
Occupational Balance
Stress
Additional relevant MeSH terms:
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Bruxism
Tooth Diseases
Stomatognathic Diseases