- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433595
Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years
A Prospective Observational Case-Control Study on the Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Başak Günay, DDS
- Phone Number: 00905072929002
- Email: dtbasakgunay@gmail.com
Study Contact Backup
- Name: Narmin Soylu, DDS
- Phone Number: 00905522824827
- Email: dt.n.mammadli@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34093
- Bezmialem Vakif University Faculty of Dentistry
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Contact:
- Başak Günay, DDS
- Phone Number: 00905072929002
- Email: dtbasakgunay@gmail.com
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Principal Investigator:
- Başak Günay, DDS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Bruxism Group
Children aged 8-11 years with clinically diagnosed bruxism.
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Control Group
Children aged 8-11 years without clinical signs of bruxism.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between child perceived stress level and bruxism status
Time Frame: Baseline
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Child perceived stress level assessed by the Perceived Stress Scale for Children (8-11 years); association with bruxism status (yes/no).
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Baseline
|
Secondary Outcome Measures
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
Sponsor
Investigators
- Study Director: Başak Günay, DDS, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08.03.2023 - E.99609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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