Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:51 PM
Study NCT ID:
NCT07433595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between child perceived stress level and bruxism status', 'timeFrame': 'Baseline', 'description': 'Child perceived stress level assessed by the Perceived Stress Scale for Children (8-11 years); association with bruxism status (yes/no).'}], 'secondaryOutcomes': [{'measure': 'Association between parenting-related stress and child bruxism status', 'timeFrame': 'Baseline', 'description': 'Parenting-related stress level assessed by the Parenting Stress Scale; association with child bruxism status.'}, {'measure': 'Association between parental perceived stress level and child bruxism status', 'timeFrame': 'Baseline', 'description': 'Parental perceived stress level assessed by the Perceived Stress Scale (PSS); association with child bruxism status.'}, {'measure': 'Association between parental awareness of child stress/anxiety and child bruxism status', 'timeFrame': 'Baseline', 'description': 'Parental awareness of child stress/anxiety assessed by the SCARED - Parent Form; association with child bruxism status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child stress', 'Parenting stress', 'Bruxism', 'Parental and child stress'], 'conditions': ['Bruxism', 'Stress', 'Parent Stress', 'Parent and Child Stress']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nChildren 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.\n\nPerceived 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren 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\n\nExclusion Criteria:\n\nAbsence of signed informed consent Presence of chronic or systemic diseases'}, 'identificationModule': {'nctId': 'NCT07433595', 'briefTitle': 'Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'A Prospective Observational Case-Control Study on the Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years', 'orgStudyIdInfo': {'id': '08.03.2023 - E.99609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bruxism Group', 'description': 'Children aged 8-11 years with clinically diagnosed bruxism.'}, {'label': 'Control Group', 'description': 'Children aged 8-11 years without clinical signs of bruxism.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Başak Günay, DDS', 'role': 'CONTACT', 'email': 'dtbasakgunay@gmail.com', 'phone': '00905072929002'}, {'name': 'Başak Günay, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem Vakif University Faculty of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Başak Günay, DDS', 'role': 'CONTACT', 'email': 'dtbasakgunay@gmail.com', 'phone': '00905072929002'}, {'name': 'Narmin Soylu, DDS', 'role': 'CONTACT', 'email': 'dt.n.mammadli@gmail.com', 'phone': '00905522824827'}], 'overallOfficials': [{'name': 'Başak Günay, DDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Basak Gunay', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}