Bezmialem Vakıf University
Istanbul, Turkey (Türkiye)
NCT Number: NCT07427004
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.
Saliva 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.
This 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).
All 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
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Notify Me6 year–12 year
All sexes
Observational
Istanbul, Turkey (Türkiye)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: One-time, baseline (July-September 2024
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva as mL/min; reflects saliva production rate. Higher values indicate greater salivary secretion
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva spectrophotometrically; reported in mmol H2O2 equivalent/L. Reflects overall oxidative stress in saliva. Higher values indicate higher oxidant levels.
Time frame: One-time, baseline (July-September 2024)
Measured in unstimulated saliva spectrophotometrically; reported in mmol Ascorbic acid equivalent/L. Reflects total antioxidant capacity of saliva. Higher values indicate greater antioxidant defense.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
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.
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Once daily", "Twice daily", "Irregular".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Less than 2 minutes", "2 minutes or more".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Yes", "Sometimes", "No".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Male", "Female".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master's degree".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Primary school", "High school", "University", "Master's degree".
Time frame: One-time, baseline (July-September 2024)
Assessed via parent-completed questionnaire. Categories: "Below minimum wage", "Up to 2x minimum wage", "Up to 3x minimum wage", "More than 3x minimum wage".
Bezmialem Vakif University
Other
Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children
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