Menu
Recruiting NCT07330570

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

Observational Early Childhood Caries (ECC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caries Risk Assesment.
Who it may be relevant to
Registry conditions: Early Childhood Caries (ECC). Basic parameters: 6 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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 wil

Primary outcome measures

  • Caries Risk Assessment [Time frame: Baseline]
Secondary outcome measures (7)
  • DMFT/dmft Scores [Time frame: Baseline]
  • Plaque Index (Silness-Löe) [Time frame: Baseline]
  • Gingival Index (Löe-Silness) [Time frame: Baseline]
  • Stimulated Salivary Flow Rate (mL/min) [Time frame: Baseline]
  • Salivary Buffering Capacity (pH) [Time frame: Baseline]
  • Probing Depth (mm) [Time frame: Baseline]
  • Fluoride Program [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Aydın Adnan Menderes University, Faculty of Dentistry — Aydin

Publications

  • American Academy of Pediatric Dentistry. (2023). Definition of Early Childhood Caries (ECC). AAPD Reference Manual.
  • Kirthiga M, Murugan M, Saikia A, Kirubakaran R. Risk Factors for Early Childhood Caries: A Systematic Review and Meta-Analysis of Case Control and Cohort Studies. Pediatr Dent. 2019 Mar 15;41(2):95-112. PMID 30992106
  • T.C. Sağlık Bakanlığı. (2004). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2004). Refik Saydam Hıfzıssıhha Merkezi Başkanlığı Yayınları.
  • T.C. Sağlık Bakanlığı. (2018). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2018). Türkiye Halk Sağlığı Kurumu Yayınları.
  • Casamassimo PS, Thikkurissy S, Edelstein BL, Maiorini E. Beyond the dmft: the human and economic cost of early childhood caries. J Am Dent Assoc. 2009 Jun;140(6):650-7. doi: 10.14219/jada.archive.2009.0250. PMID 19491160
  • Kim Seow W. Environmental, maternal, and child factors which contribute to early childhood caries: a unifying conceptual model. Int J Paediatr Dent. 2012 May;22(3):157-68. doi: 10.1111/j.1365-263X.2011.01186.x. Epub 2011 Oct 4. PMID 21972925
  • Oubenyahya H, Bouhabba N. General anesthesia in the management of early childhood caries: an overview. J Dent Anesth Pain Med. 2019 Dec;19(6):313-322. doi: 10.17245/jdapm.2019.19.6.313. Epub 2019 Dec 27. PMID 31942447
  • Patel S, Fantauzzi AJ, Patel R, Buscemi J, Lee HH. Childhood caries and dental surgery under general anesthesia: an overview of a global disease and its impact on anesthesiology. Int Anesthesiol Clin. 2023 Jan 1;61(1):21-25. doi: 10.1097/AIA.0000000000000385. Epub 2022 Nov 17. PMID 36480646

Identifiers

NCT: NCT07330570 · EErsan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗