BruxismNCT07433595
Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years
An observational study of Bruxism and Stress, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Stress, Parent Stress
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Absence of signed informed consent Presence of chronic or systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Dentistry
Istanbul, 34093
Başak Günay, DDS, 00905072929002, dtbasakgunay@gmail.com
Başak Günay, DDS
About this study
Official title: 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.
Read the 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.
- Conditions
- Bruxism, Stress, Parent Stress, Parent and Child Stress
- Keywords
- Child stress, Parenting stress, Bruxism, Parental and child stress
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Association between child perceived stress level and bruxism status
Child perceived stress level assessed by the Perceived Stress Scale for Children (8-11 years); association with bruxism status (yes/no).
Measured: Baseline
Secondary outcomes (3)
Association between parenting-related stress and child bruxism status
Parenting-related stress level assessed by the Parenting Stress Scale; association with child bruxism status.
Measured: Baseline
Association between parental perceived stress level and child bruxism status
Parental perceived stress level assessed by the Perceived Stress Scale (PSS); association with child bruxism status.
Measured: Baseline
Association between parental awareness of child stress/anxiety and child bruxism status
Parental awareness of child stress/anxiety assessed by the SCARED - Parent Form; association with child bruxism status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion15 Apr 2026 (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.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Gunay, Bezmialem Vakif University
- Investigators
- Başak Günay, DDS, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433595
- Sponsor's protocol ID
- 08.03.2023 - E.99609
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Case-Control Study on the Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years
- ClinicalTrials.gov ID
- NCT07433595
- Acronym / sponsor ID
- 08.03.2023 - E.99609
- Conditions
- Bruxism, Stress, Parent Stress, Parent and Child Stress
- Keywords
- Child stress, Parenting stress, Bruxism, Parental and child stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism Group | – | –Children aged 8-11 years with clinically diagnosed bruxism. |
| Control Group | – | –Children aged 8-11 years without clinical signs of bruxism. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Absence of signed informed consent Presence of chronic or systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Association between parenting-related stress and child bruxism status
Time frame: Baseline
Association between parental perceived stress level and child bruxism status
Time frame: Baseline
Association between parental awareness of child stress/anxiety and child bruxism status
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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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.
Başak Günay, DDS study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism and Stress, run by Bezmialem Vakif 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 1 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Başak Günay, DDS (00905072929002, dtbasakgunay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between child perceived stress level and bruxism status (time frame: Baseline). 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 Feb 2026.