Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Dental caries severity
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-12 years
- •Children with no systemic diseases
排除标准
- •Children with systemic or local conditions affecting salivary secretion (diabetes, salivary gland infections, sialoliths, or neurological disorders)
- •Children who had used medications affecting salivary secretion in the past three months (antimuscarinics, antihypertensives, or antidepressants)
- •Children whose legal guardian did not provide written informed consent
- •Children with the history of chemotheraphy or radiotherapy
- •Children who are uncooperative with salivary sampling
研究组 & 干预措施
Study Group: Advanced Caries
Study Group (Advanced Caries):
Children aged 6-12 years with advanced dental caries (ICDAS codes II 5-6). All participants were systemically healthy and of Turkish ethnicity.
Contol Group: Caries-Free / Mild-Moderate Caries
Control Group (Caries-Free / Mild-Moderate Caries):
Children 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.
结局指标
主要结局
Dental caries severity
时间窗: 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.
Cumulative caries experience
时间窗: 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.
Periodontal status - Plaque index
时间窗: 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.
Periodontal status - Gingival index
时间窗: 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.
Periodontal status - Bleeding on Probing (BOP)
时间窗: 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.
Salivary flow rate
时间窗: One-time, baseline (July-September 2024)
Measured in unstimulated saliva as mL/min; reflects saliva production rate. Higher values indicate greater salivary secretion
Salivary pH
时间窗: 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.
Salivary buffering capacity
时间窗: 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.
Salivary melatonin
时间窗: 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.
Salivary cortisol
时间窗: 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.
Salivary IL-6
时间窗: 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.
Total oxidant status (TOS)
时间窗: 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.
Total antioxidant status (TAS)
时间窗: 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.
Oxidative stress index (OSI)
时间窗: 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.
Sleep disturbances
时间窗: 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.
次要结局
- Child's toothbrushing frequency(One-time, baseline (July-September 2024))
- Child's toothbrushing duration(One-time, baseline (July-September 2024))
- Parental assistance during toothbrushing(One-time, baseline (July-September 2024))
- Regular dental floss use(One-time, baseline (July-September 2024))
- Regular mouthwash use(One-time, baseline (July-September 2024))
- Child's sex(One-time, baseline (July-September 2024))
- Father's education level(One-time, baseline (July-September 2024))
- Mother's education level(One-time, baseline (July-September 2024))
- Family monthly income(One-time, baseline (July-September 2024))