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NCT Number: NCT07330570

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydın Adnan Menderes University, Faculty of Dentistry

Aydin, Aydın, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ebru Ersan

CONTACT

About this study

Early childhood caries (ECC) is defined as the presence of one or more decayed, missing, or filled primary teeth in children, particularly those aged 71 months or younger. ECC is one of the most common chronic diseases of childhood, with a prevalence reaching up to 70% in communities with low socioeconomic status. According to the data from the Turkish Oral and Dental Health Profile studies, while a decrease in the average number of decayed teeth and dmft index was observed in 2018 compared to 2004, an increase in the average number of filled and missing teeth was detected. Although this demonstrates improved access to caries treatment services, the persistently high prevalence of ECC indicates a continuing need for effective preventive strategies.

In the treatment of ECC, particularly in younger children with extensive caries and challenging behavior management, dental interventions are frequently performed under general anesthesia (GA). However, long-term follow-up studies have shown insufficient attention to oral hygiene and limited access to preventive applications among children treated under GA. Research on this patient group reveals a high incidence of recurrent caries after treatment. These findings indicate that approaches focusing solely on treatment are insufficient, as the risk of caries persists, and these individuals require long-term, structured follow-up.

The aim of this thesis study is to objectively evaluate the current caries risk levels of individuals who underwent dental treatment under GA for ECC. For this purpose, children treated for ECC under GA at Aydın Adnan Menderes University Faculty of Dentistry between 2015 and 2020 will be recalled, and their current caries risk profiles will be analyzed using the Cariogram model, the most up-to-date official web-based version available at "cariogram.uni.mau.se".

Caries risk assessment will be performed using a comprehensive set of parameters integrated into the Cariogram model, including:

  • Clinical caries experience (DMFT/dmft indices),
  • Oral hygiene status (Plaque Index, Gingival Index, probing depth),
  • Salivary factors (stimulated flow rate, buffer capacity,)
  • Diet content and frequency,
  • Fluoride exposure,
  • Socioeconomic status,
  • Past dental history and frequency of dental visits,
  • General health and medication use.

Each parameter will be scored according to standardized criteria. Participants will be invited only once, and the study will have a cross-sectional design, with data collection completed in a single visit.

This research will provide scientific data for monitoring and protecting high-risk pediatric populations at both individual and community levels in the fight against caries. Furthermore, the findings are expected to contribute to the planning of preventive oral health services and the development of oral health policies. By examining the course of caries risk in individuals treated under GA for ECC in later years, this study will help better understand the need for preventive care in this population. These evaluations will not only reveal the current situation but also contribute to the development of effective and sustainable preventive service models for these individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Caries Risk Assessment

    Time frame: 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

Secondary outcomes

  1. DMFT/dmft Scores

    Time frame: Baseline

    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

  2. Plaque Index (Silness-Löe)

    Time frame: Baseline

    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

    • Thin visible plaque, difficult to detect
    • Thick visible plaque, easily detectable
    • 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)

  3. Gingival Index (Löe-Silness)

    Time frame: Baseline

    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

  4. Stimulated Salivary Flow Rate (mL/min)

    Time frame: Baseline

    Stimulated salivary flow rate will be measured using wax-stimulated saliva collection and expressed in mL/min.

    0: ≥0.7 mL/min

    • 0.3-0.7 mL/min
    • <0.3 mL/min
  5. Salivary Buffering Capacity (pH)

    Time frame: Baseline

    Salivary buffering capacity will be assessed using Dentobuff test strips to measure salivary pH.

    0: pH ≥6.0

    • pH 4.5-5.5
    • pH ≤4.0
  6. Probing Depth (mm)

    Time frame: Baseline

    Probing depth refers to the distance (in millimeters) between the gingival margin and the deepest point of the periodontal tissues surrounding the tooth that can be probed. This measurement is performed using a special instrument called a periodontal probe, which has a rounded tip and is calibrated in millimeters.

    1-3 mm: Healthy gingiva/sulcus, 4 mm: Initial periodontal disease, 5-6 mm: Moderate periodontitis, ≥7 mm: Advanced periodontitis

  7. Fluoride Program

    Time frame: Baseline

    The amount of fluoride present in the mouth. Obtained through interview. 0: Maximum Program, 1: Supplement, 2: Toothpaste Only, 3: No Fluoride

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru Ersan

CONTACT

[email protected]

05547350346

Melis Akyıldız

CONTACT

[email protected]

05387970703

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Evaluation of Current Caries Risk in Children Treated Under General Anesthesia Due to Early Childhood Caries Between 2015-2020

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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