Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years

February 20, 2026 updated by: Basak Gunay, Bezmialem Vakif University

A Prospective Observational Case-Control Study on the Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years

This prospective observational case-control study aims to evaluate the association between perceived stress levels in children and their parents and the presence of clinically diagnosed bruxism in children aged 8-11 years. Children with bruxism and age-matched controls will be recruited from the Department of Pediatric Dentistry. Child perceived stress, parental perceived stress, parenting-related stress, and parental awareness of child stress/anxiety will be assessed using validated questionnaires. Associations between stress-related measures and bruxism status will be analyzed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a prospective observational case-control study designed to investigate the association between perceived stress levels in children and their parents and the presence of clinically diagnosed bruxism in children aged 8-11 years. Participants will be recruited from children presenting to the Department of Pediatric Dentistry at Bezmialem Vakıf University Faculty of Dentistry for dental treatment.

Children will be allocated into two groups based on clinical evaluation: a bruxism group consisting of children diagnosed with bruxism, and a control group consisting of children without clinical signs of bruxism. Bruxism diagnosis will be established using parental reports and standardized clinical examination findings, including tooth wear assessed according to the Smith and Knight Tooth Wear Index, temporomandibular joint findings, masticatory muscle symptoms, and intraoral soft tissue signs.

Perceived stress levels in children will be assessed using the Perceived Stress Scale for Children (8-11 years). Parenting-related stress will be evaluated using the Parenting Stress Scale. Parents' own perceived stress levels will be measured using the Perceived Stress Scale (PSS). Parental awareness of the child's stress and anxiety will be assessed using the parent form of the Screen for Child Anxiety Related Emotional Disorders (SCARED) developed by Birmaher et al.

All assessments will be conducted at baseline during the clinical visit. The primary outcome is the association between child perceived stress levels and bruxism status. Secondary outcomes include associations between parental stress-related measures and child bruxism status. Statistical analyses will be performed to evaluate group differences and associations between stress measures and the presence of bruxism.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif University Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Başak Günay, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of children aged 8-11 years who present to the Department of Pediatric Dentistry at Bezmialem Vakıf University Faculty of Dentistry for dental treatment, along with their parents. Children will be classified into the bruxism and control groups based on clinical examination and parental reports.

Description

Inclusion Criteria:

Children aged 8-11 years Mixed or permanent dentition Presentation to the Department of Pediatric Dentistry For bruxism group: clinically diagnosed bruxism For control group: absence of clinical signs of bruxism Written informed consent obtained from parent/legal guardian

Exclusion Criteria:

Absence of signed informed consent Presence of chronic or systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Bruxism Group
Children aged 8-11 years with clinically diagnosed bruxism.
Control Group
Children aged 8-11 years without clinical signs of bruxism.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Association between child perceived stress level and bruxism status
Time Frame: Baseline
Child perceived stress level assessed by the Perceived Stress Scale for Children (8-11 years); association with bruxism status (yes/no).
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association between parenting-related stress and child bruxism status
Time Frame: Baseline
Parenting-related stress level assessed by the Parenting Stress Scale; association with child bruxism status.
Baseline
Association between parental perceived stress level and child bruxism status
Time Frame: Baseline
Parental perceived stress level assessed by the Perceived Stress Scale (PSS); association with child bruxism status.
Baseline
Association between parental awareness of child stress/anxiety and child bruxism status
Time Frame: Baseline
Parental awareness of child stress/anxiety assessed by the SCARED - Parent Form; association with child bruxism status.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Başak Günay, DDS, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08.03.2023 - E.99609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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