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

December 29, 2025 updated by: Melis AKYILDIZ, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Aydın
      • Aydin, Aydın, Turkey (Türkiye)
        • Recruiting
        • Aydın Adnan Menderes University, Faculty of Dentistry
        • Contact:
          • Ebru Ersan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Group- Children with Early Childhood Caries Treated under GA
This study includes a single group of systemically healthy children aged 6-16 years who underwent dental treatment under general anesthesia for early childhood caries (ECC) between 2015 and 2020 at Aydın Adnan Menderes University Faculty of Dentistry.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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

  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)
Baseline
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
Baseline
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

  1. 0.3-0.7 mL/min
  2. <0.3 mL/min
Baseline
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

  1. pH 4.5-5.5
  2. pH ≤4.0
Baseline
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
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Melis Akyıldız, Aydın Adnan Menderes University, Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EErsan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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