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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorAydin Adnan Menderes University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Children aged 6-16 years who underwent dental treatment under general anesthesia for early childhood caries (ECC) at Aydın Adnan Menderes University, Faculty of Dentistry between 2015-2020

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Caries Risk Assesment

    Diagnostic test

    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.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Single Group- Children with Early Childhood Caries Treated under GA1 intervention

Trial outcomes

Primary outcomes

1

Caries Risk Assessment

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

Time frame
Baseline

Secondary outcomes

1

DMFT/dmft Scores

DMFT/dfs index in individuals consists of the following components: D (Decayed): Number of decayed and untreated permanent teeth M (Missing): Number of permanent teeth extracted due to caries F (Filled): Number of permanent teeth restored with fillings T(Teeth) For each participant, these three components will be recorded separately, and the total DMFT score will be calculated. 0: DMFT=0, 1: DMFT=1, 2: DMFT=2, 3: DMFT ≥ 3

Time frame
Baseline
2

Plaque Index (Silness-Löe)

Oral hygiene status will be assessed using the standardized Plaque Index criteria on specified tooth surfaces. Plaque Index (PI) - Silness and Löe 0: No plaque 1. Thin visible plaque, difficult to detect 2. Thick visible plaque, easily detectable 3. Presence of plaque filling the interproximal area 0: 0 (Excellent), 1: 0.1-0.9 (Good), 2: 1.0-1.9 (Moderate), 3: 2.0-3.0 (Poor)

Time frame
Baseline
3

Gingival Index (Löe-Silness)

Gingival health will be measured using the Gingival Index to evaluate the degree of gingival inflammation. 0: Normal gingiva - no edema, 1: Mild edema, no bleeding after gentle probing, 2: Moderate to severe gingival edema, bleeding after air drying, 3: Severe inflammation; redness and edema. Ulceration. Tendency for spontaneous bleeding

Time frame
Baseline
4

Stimulated Salivary Flow Rate (mL/min)

Stimulated salivary flow rate will be measured using wax-stimulated saliva collection and expressed in mL/min. 0: ≥0.7 mL/min 1. 0.3-0.7 mL/min 2. \<0.3 mL/min

Time frame
Baseline

Other outcomes

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