Aydın Adnan Menderes University, Faculty of Dentistry
Aydin, Aydın, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ebru Ersan
CONTACT
NCT Number: NCT07330570
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.
Interested in participating?
Request Info6 year–16 year
All sexes
Observational
Aydin, Aydın, Turkey (Türkiye)
Location status: Recruiting
Ebru Ersan
CONTACT
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
0: 0 (Excellent), 1: 0.1-0.9 (Good), 2: 1.0-1.9 (Moderate), 3: 2.0-3.0 (Poor)
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
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
Time frame: Baseline
Salivary buffering capacity will be assessed using Dentobuff test strips to measure salivary pH.
0: pH ≥6.0
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
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
Contact information is provided by the study sponsor or research team.
Ebru Ersan
CONTACT
Melis Akyıldız
CONTACT
Aydin Adnan Menderes University
Other
The Evaluation of Current Caries Risk in Children Treated Under General Anesthesia Due to Early Childhood Caries Between 2015-2020
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