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

NCT07330570 | Recruiting

• 1 other identifier: EErsan
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries (ECC)

Keywords

General Anesthesia; Pediatric Dentistry; Cariogram; Caries Risk Factors

Outcome Measures

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

  Baseline

Secondary Outcomes (7)

• DMFT/dmft Scores

  Baseline

• Plaque Index (Silness-Löe)

  Baseline

• Gingival Index (Löe-Silness)

  Baseline

• Stimulated Salivary Flow Rate (mL/min)

  Baseline

• Salivary Buffering Capacity (pH)

  Baseline

Study Arms (1)

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

Interventions

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.

Single Group- Children with Early Childhood Caries Treated under GA

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Dentistry

Aydin, Aydın, Turkey (Türkiye)

RECRUITING

Related Publications (20)

• American Academy of Pediatric Dentistry. (2023). Definition of Early Childhood Caries (ECC). AAPD Reference Manual.

  BACKGROUND

• 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 BACKGROUND

• T.C. Sağlık Bakanlığı. (2004). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2004). Refik Saydam Hıfzıssıhha Merkezi Başkanlığı Yayınları.

  BACKGROUND

• T.C. Sağlık Bakanlığı. (2018). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2018). Türkiye Halk Sağlığı Kurumu Yayınları.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Li JY, He SY, Wang PX, Dai SS, Zhang SQ, Li ZY, Guo QY, Liu F. Incidence and risk factors of unplanned retreatment following dental general anesthesia in children with severe early childhood caries. Front Pediatr. 2023 Jul 27;11:1163368. doi: 10.3389/fped.2023.1163368. eCollection 2023.

  PMID: 37576136 BACKGROUND

• Featherstone JD. The continuum of dental caries--evidence for a dynamic disease process. J Dent Res. 2004;83 Spec No C:C39-42. doi: 10.1177/154405910408301s08.

  PMID: 15286120 BACKGROUND

• Bratthall D, Hansel Petersson G. Cariogram--a multifactorial risk assessment model for a multifactorial disease. Community Dent Oral Epidemiol. 2005 Aug;33(4):256-64. doi: 10.1111/j.1600-0528.2005.00233.x.

  PMID: 16008632 BACKGROUND

• Twetman S, Fontana M, Featherstone JD. Risk assessment - can we achieve consensus? Community Dent Oral Epidemiol. 2013 Feb;41(1):e64-70. doi: 10.1111/cdoe.12026.

  PMID: 24916679 BACKGROUND

• Taqi M, Zaidi SJA. Predictive validity of the reduced Cariogram model for caries increment in non-cavitated and cavitated lesions: cohort study. BMC Oral Health. 2023 Oct 24;23(1):790. doi: 10.1186/s12903-023-03479-w.

  PMID: 37875839 BACKGROUND

• Gao XL, Hsu CY, Xu Y, Hwarng HB, Loh T, Koh D. Building caries risk assessment models for children. J Dent Res. 2010 Jun;89(6):637-43. doi: 10.1177/0022034510364489. Epub 2010 Apr 16.

  PMID: 20400721 BACKGROUND

• Campus G, Cagetti MG, Sale S, Carta G, Lingstrom P. Cariogram validity in schoolchildren: a two-year follow-up study. Caries Res. 2012;46(1):16-22. doi: 10.1159/000334932. Epub 2012 Jan 4.

  PMID: 22222621 BACKGROUND

• Utreja, D., Singh, A., Purohit, B. M., & Purohit, R. N. (2019). Application of Cariogram in Caries Risk Assessment Among Schoolchildren in India. Oral Health & Preventive Dentistry, 17(2), 133-138

  BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• Al Shayeb KN, Turner W, Gillam DG. Periodontal probing: a review. Prim Dent J. 2014 Aug;3(3):25-9. doi: 10.1308/205016814812736619.

  PMID: 25198634 BACKGROUND

• Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.

  PMID: 27672245 BACKGROUND

• Cavalcante, G. M. S., Teles, R. P., Scarparo, R. K., Silva, M. E. R., & Mialhe, F. L. (2014). Dental caries experience among children with cerebral palsy in Brazil: A case-control study. Journal of Applied Oral Science, 22(3), 215-220. https://doi.org/10.1590/1678-775720130689

  BACKGROUND

Study Officials

• Melis Akyıldız

  Aydın Adnan Menderes University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melis Akyıldız

CONTACT

05387970703; baharmeliss@hotmail.com

Ebru Ersan

CONTACT

05547350346; ebruersan96@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 9, 2026
• Study Start: May 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-09

Locations

TU (1)