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Recruiting Observational

Caries Risk in Children Treated Under General Anesthesia for Early Childhood Caries

NCT07330570 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-05-07
Last updated
2026-01-09

Condition(s) studied

Early Childhood Caries (ECC)

Investigational drug(s) / intervention(s)

Caries Risk Assesment

Caries Risk Assesment: Participants will undergo a single-visit evaluation in which caries risk will be comprehensively assessed using the Cariogram model. The assessment will integrate findings from clinical examination (including DMFT/dmft scores, Plaque Index, Gingival Index, and probing depth), salivary analysis (stimulated flow rate and buffer capacity), and standardized questionnaires evaluating diet, fluoride exposure, socioeconomic status, and dental visit history. No treatment or experimental intervention will be performed; all data will be collected exclusively for observational analysis.

Study summary

This observational, cross-sectional study aims to evaluate the current caries risk profiles of children who underwent dental treatment under general anesthesia (GA) for early childhood caries (ECC) between 2015 and 2020 at Aydın Adnan Menderes University, Faculty of Dentistry. A minimum of 44 systemically healthy children will be included.

Caries risk will be assessed using the Cariogram model, incorporating clinical parameters (DMFT/dmft, Plaque Index, Gingival Index, probing depth), salivary factors (stimulated flow rate, buffer capacity), and standardized questionnaires covering diet, fluoride exposure, socioeconomic status, and dental visit history. Data will be collected in a single visit, analyzed using SPSS.

The study aims to provide scientific evidence for long-term preventive strategies and oral health policies targeting high-risk pediatric populations treated under GA for ECC.

Eligibility

Sex
ALL
Min age
6 Years
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Pediatric patients who underwent dental treatment under general anesthesia for early childhood caries (ECC) at the Department of Pediatric Dentistry, Faculty of Dentistry, Aydın Adnan Menderes University between 2015-2020 * Patients whose follow-up information (e.g., discharge summary, treatment plan) is accessible through clinical records * Individuals who provide written informed consent signed by their parents/legal guardians and assent from the child to participate in the study Exclusion Criteria: * Individuals with medical conditions that may affect oral health, such as systemic diseases, immunodeficiencies, or chronic illnesses * Children with special healthcare needs or mental/physical disabilities * Patients who do not cooperate during the examination or do not allow the completion of the oral examination

Primary outcome measure(s)

  • Caries Risk Assessment — Baseline
    Caries risk will be evaluated using the Cariogram model, which combines clinical, salivary, behavioral, and socioeconomic factors to estimate each participant's "chance to avoid caries." Key inputs include caries experience (DMFT/dmft), plaque and gingival status, salivary flow and buffering, diet and oral hygiene habits, fluoride exposure, dental attendance, and socioeconomic or health-related influences. The Cariogram software will integrate these variables to generate a visual risk profile and a final percentage score for objective comparison between participants. The following parameters are evaluated in the Cariogram: Caries History Systemic disease: 0: No disease, 1: a mild systemic disease, 2: Severely affecting systemic diseaseDietary content: the cariogenic potential of foods 0: ≤ 10³ CFU/ml, 1: 10⁴ CFU/ ml, 2: 10⁵ CFU/ml, 3: ≥10⁶ CFU/ml Diet frequency: Average daily number of meals and snacks 0≤ 3 meals/day, 1: 4-5 meals/day, 2: 6-7 meals/day, 3: \>7 meals/day

Trial sites (1)

FacilityCityRegionStatus
Aydın Adnan Menderes University, Faculty of Dentistry Aydin Aydın Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07330570 on ClinicalTrials.gov ↗ ← All trials in Turkey