BruxismNCT06052709
Investigation of Occupational Balance in Individuals With and Without Bruxism
A study testing Occupational balance assessment in people with Bruxism and Occupational Problems, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Occupational Problems
- What is being tested?
- Occupational balance assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be volunteer
Who cannot join
- Psychological disorders,
- Neurological disorders,
- Orthopedic disorders,
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, 60250
Halime ARIKAN, PhD, +90 546 576 51 32, halimearikan92@gmail.com
About this study
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.
Read the 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.
- Conditions
- Bruxism, Occupational Problems
- Being tested
- Occupational balance assessment
- Keywords
- Bruxism, Occupational Balance, Stress
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational balance assessmentOther
There is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Occupational balance assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052709
- Sponsor's protocol ID
- 13.20
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Occupational Balance in Individuals With and Without Bruxism
- ClinicalTrials.gov ID
- NCT06052709
- Acronym / sponsor ID
- 13.20
- Conditions
- Bruxism, Occupational Problems
- Keywords
- Bruxism, Occupational Balance, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with bruxism | Active comparator | Other: Occupational balance assessmentAfter 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. |
| Individuals without bruxism | Placebo comparator | Other: Occupational balance assessmentAfter 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be volunteer
Key exclusion criteria (4 listed)
- Psychological disorders,
- Neurological disorders,
- Orthopedic disorders,
- Cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational balance assessmentThere is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated. | Other | Individuals with bruxism, Individuals without bruxism |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational balance assessment in people with Bruxism and Occupational Problems, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halime ARIKAN, PhD (+90 546 576 51 32, halimearikan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fonseca Anamnestic Index (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.