Clinical Trials Directory

Trials / Completed

CompletedNCT07427004

Sleep Problems, Salivary Biomarkers, Dental Caries and Periodontal Status in School-Aged Children

Evaluation of the Relationship Between Sleep Disorders and Salivary Parameters With Dental Caries in School-Aged Children

Status
Completed
Phase
Study type
Observational
Enrollment
73 (actual)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Accepted

Summary

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

Conditions

Timeline

Start date
2024-07-10
Primary completion
2024-09-10
Completion
2024-09-30
First posted
2026-02-23
Last updated
2026-02-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07427004. Inclusion in this directory is not an endorsement.