Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:42 AM
Study NCT ID:
NCT07427004
Status:
COMPLETED
Last Update Posted:
2026-02-23
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Problems, Salivary Biomarkers, Dental Caries and Periodontal Status in School-Aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Unstimulated saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental caries severity', 'timeFrame': 'One-time, baseline (July-September 2024', 'description': 'Assessed using the International Caries Detection and Assessment System (ICDAS II, codes 0-6) for each primary and permanent tooth. Higher codes indicate more severe lesions. 0 = sound, 1 = first visual change in enamel, 2 = distinct visual change, 3 = localized enamel breakdown, 4 = underlying dark shadow, 5 = distinct cavity, 6 = extensive cavity.'}, {'measure': 'Cumulative caries experience', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed using the DMFT + dmft index to record the total number of decayed (D/d), missing (M/m) and filled (F/f) teeth in permanent and primary dentition.'}, {'measure': 'Periodontal status - Plaque index', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Plaque accumulation assessed on all teeth using the Silness-Löe plaque index (score 0-3). 0 = no plaque, 1 = slight plaque visible, 2 = moderate plaque, 3 = abundant plaque. Higher scores indicate more plaque accumulation.'}, {'measure': 'Periodontal status - Gingival index', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Gingival inflammation assessed on all teeth using the Silness-Löe gingival index (score range 0-3). Scores obtained from each tooth. Score interpretation: 0 = normal gingiva, 1 = mild inflammation (slight color change, no bleeding), 2 = moderate inflammation (redness, swelling, slight bleeding), 3 = severe inflammation (marked redness/swelling, bleeding on probing). Higher scores indicate more severe inflammation.'}, {'measure': 'Periodontal status - Bleeding on Probing (BOP)', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Bleeding on probing assessed on all teeth using the Ainamo \\& Bay index. Each site was gently probed; presence or absence of bleeding was recorded. Score interpretation: - = no bleeding, + = bleeding present. The percentage of bleeding sites relative to total sites was calculated per participant. Higher percentages indicate greater gingival inflammation.'}, {'measure': 'Salivary flow rate', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva as mL/min; reflects saliva production rate. Higher values indicate greater salivary secretion'}, {'measure': 'Salivary pH', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva using a digital pH meter; reported in pH units. Higher values indicate more alkaline saliva, lower values indicate more acidic saliva.'}, {'measure': 'Salivary buffering capacity', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': "Salivary buffering capacity measured using the Ericsson method, reflecting saliva's ability to neutralize acids and maintain pH homeostasis. Reported as a score/units; higher values indicate greater buffering capacity."}, {'measure': 'Salivary melatonin', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva using ELISA; reported in ng/mL. Melatonin is a hormone involved in sleep regulation and antioxidant defense. Higher values indicate higher melatonin levels.'}, {'measure': 'Salivary cortisol', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva using ELISA; reported in ng/mL. Cortisol is a hormone related to stress response and sleep regulation. Higher values indicate higher cortisol levels.'}, {'measure': 'Salivary IL-6', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva using ELISA; reported in pg/mL. IL-6 is a pro-inflammatory cytokine reflecting oral and systemic inflammation. Higher values indicate higher inflammatory status.'}, {'measure': 'Total oxidant status (TOS)', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva spectrophotometrically; reported in mmol H2O2 equivalent/L. Reflects overall oxidative stress in saliva. Higher values indicate higher oxidant levels.'}, {'measure': 'Total antioxidant status (TAS)', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Measured in unstimulated saliva spectrophotometrically; reported in mmol Ascorbic acid equivalent/L. Reflects total antioxidant capacity of saliva. Higher values indicate greater antioxidant defense.'}, {'measure': 'Oxidative stress index (OSI)', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Calculated as the ratio of TOS to TAS; unitless. Reflects the balance between oxidants and antioxidants in saliva. Higher values indicate higher oxidative stress relative to antioxidant capacity.'}, {'measure': 'Sleep disturbances', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed using the Sleep Disturbance Scale for Children (SDSC, total score ranging from 26 to 130) over the previous 6 months. Higher scores indicate greater risk or severity of sleep problems. A cutoff of 42 points is used; scores above this suggest an increased likelihood of sleep disturbances.'}], 'secondaryOutcomes': [{'measure': "Child's toothbrushing frequency", 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Once daily", "Twice daily", "Irregular".'}, {'measure': "Child's toothbrushing duration", 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Less than 2 minutes", "2 minutes or more".'}, {'measure': 'Parental assistance during toothbrushing', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".'}, {'measure': 'Regular dental floss use', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".'}, {'measure': 'Regular mouthwash use', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".'}, {'measure': "Child's sex", 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Male", "Female".'}, {'measure': "Father's education level", 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master\'s degree".'}, {'measure': "Mother's education level", 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master\'s degree".'}, {'measure': 'Family monthly income', 'timeFrame': 'One-time, baseline (July-September 2024)', 'description': 'Assessed via parent-completed questionnaire. Categories: "Below minimum wage", "Up to 2x minimum wage", "Up to 3x minimum wage", "More than 3x minimum wage".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Sleep Problems', 'Periodontal Status']}, 'descriptionModule': {'briefSummary': 'Dental caries is one of the most prevalent chronic diseases in childhood. In addition to established etiological factors such as dietary habits and oral hygiene, biological and behavioral factors-including sleep disturbances and salivary biochemical characteristics-may contribute to caries development and periodontal health.\n\nSaliva plays a critical role in maintaining oral homeostasis through its physical properties (flow rate, pH, and buffering capacity) and biochemical components. Salivary biomarkers such as melatonin, cortisol, interleukin-6 (IL-6) and oxidative stress parameters (total oxidant status \\[TOS\\], total antioxidant status \\[TAS\\], and oxidative stress index \\[OSI\\]) are associated with sleep regulation, stress response, inflammation and immune function.\n\nThis cross-sectional study aims to evaluate the relationship between sleep disturbances and salivary parameters as well as dental caries severity and periodontal status in children aged 6-12 years. A total of 73 children are categorized into two groups according to the International Caries Detection and Assessment System (ICDAS II): children with high-grade caries (codes 5-6) and children who are caries-free or have initial to moderate caries (codes 0-4).\n\nAll participants undergo a comprehensive oral examination to assess caries experience, plaque index, gingival index and bleeding on probing. Unstimulated saliva samples are collected to determine salivary flow rate, pH, buffering capacity, melatonin, cortisol, IL-6, TOS, TAS, and OSI levels. Sleep disturbances are evaluated using the Sleep Disturbance Scale for Children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 73 healthy children aged 6-12 years (42 boys and 31 girls) were included in the study. The participants were divided into two groups: the study group (39 children with advanced dental caries, ICDAS II codes 5-6) and the control group (34 children who were caries-free or had initial-moderate caries, ICDAS II codes 0-4). Children with systemic diseases, conditions affecting salivary secretion, or recent use of medications influencing saliva were excluded. Written informed consent was obtained from the parents or legal guardians of all participants. Only children of Turkish ethnicty were included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-12 years\n* Children with no systemic diseases\n\nExclusion Criteria:\n\n* Children with systemic or local conditions affecting salivary secretion (diabetes, salivary gland infections, sialoliths, or neurological disorders)\n* Children who had used medications affecting salivary secretion in the past three months (antimuscarinics, antihypertensives, or antidepressants)\n* Children whose legal guardian did not provide written informed consent\n* Children with the history of chemotheraphy or radiotherapy\n* Children who are uncooperative with salivary sampling'}, 'identificationModule': {'nctId': 'NCT07427004', 'briefTitle': 'Sleep Problems, Salivary Biomarkers, Dental Caries and Periodontal Status in School-Aged Children', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children', 'orgStudyIdInfo': {'id': '20240210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group: Advanced Caries', 'description': 'Study Group (Advanced Caries):\n\nChildren aged 6-12 years with advanced dental caries (ICDAS codes II 5-6). All participants were systemically healthy and of Turkish ethnicity.'}, {'label': 'Contol Group: Caries-Free / Mild-Moderate Caries', 'description': 'Control Group (Caries-Free / Mild-Moderate Caries):\n\nChildren aged 6-12 years with no or mild-moderate dental caries (ICDAS II codes 0-4).All participants were systemically healthy and of Turkish ethnicity.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}