Early Childhood Caries (ECC)NCT07330570
Caries Risk in Children Treated Under General Anesthesia for Early Childhood Caries
An observational study of Early Childhood Caries (ECC), run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries (ECC)
- What is being tested?
- Caries Risk Assesment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University, Faculty of Dentistry
Aydin, Aydın
Ebru Ersan
About this study
Official title: 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.
Read the 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.
- Conditions
- Early Childhood Caries (ECC)
- Being tested
- Caries Risk Assesment
- Keywords
- General Anesthesia, Pediatric Dentistry, Cariogram, Caries Risk Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries Risk AssesmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Caries Risk Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
DMFT/dmft Scores
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
Measured: Baseline
Plaque Index (Silness-Löe)
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)
Measured: Baseline
Gingival Index (Löe-Silness)
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
Measured: Baseline
Stimulated Salivary Flow Rate (mL/min)
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
Measured: Baseline
Salivary Buffering Capacity (pH)
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
Measured: Baseline
Probing Depth (mm)
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
Measured: Baseline
Fluoride Program
The amount of fluoride present in the mouth. Obtained through interview. 0: Maximum Program, 1: Supplement, 2: Toothpaste Only, 3: No Fluoride
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start7 May 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Caries (ECC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Melis Akyıldız, Principal investigator, Aydın Adnan Menderes University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330570
- Sponsor's protocol ID
- EErsan
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30992106T.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.
PubMed 19491160Kim 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.
PubMed 21972925Oubenyahya 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.
PubMed 31942447Patel 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.
PubMed 36480646Li 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.
PubMed 37576136Featherstone 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.
PubMed 15286120Bratthall 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.
PubMed 16008632Twetman 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.
PubMed 24916679Taqi 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.
PubMed 37875839Gao 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.
PubMed 20400721Campus 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.
PubMed 22222621
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Current Caries Risk in Children Treated Under General Anesthesia Due to Early Childhood Caries Between 2015-2020
- ClinicalTrials.gov ID
- NCT07330570
- Acronym / sponsor ID
- EErsan
- Conditions
- Early Childhood Caries (ECC)
- Keywords
- General Anesthesia, Pediatric Dentistry, Cariogram, Caries Risk Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group- Children with Early Childhood Caries Treated under GA | – | Diagnostic Test: Caries Risk AssesmentThis 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caries Risk AssesmentParticipants 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. | Diagnostic test | Single Group- Children with Early Childhood Caries Treated under GA |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- BackgroundAmerican Academy of Pediatric Dentistry. (2023). Definition of Early Childhood Caries (ECC). AAPD Reference Manual.
- Background: PubMed 30992106Kirthiga 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.
- BackgroundT.C. Sağlık Bakanlığı. (2004). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2004). Refik Saydam Hıfzıssıhha Merkezi Başkanlığı Yayınları.
- BackgroundT.C. Sağlık Bakanlığı. (2018). Türkiye Ağız ve Diş Sağlığı Profili (TADSAP-2018). Türkiye Halk Sağlığı Kurumu Yayınları.
- Background: PubMed 19491160Casamassimo 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.
- Background: PubMed 21972925Kim 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.
- Background: PubMed 31942447Oubenyahya 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.
- Background: PubMed 36480646Patel 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.
- Background: PubMed 37576136Li 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.
- Background: PubMed 15286120Featherstone 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.
- Background: PubMed 16008632Bratthall 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.
- Background: PubMed 24916679Twetman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melis Akyıldız principal investigator
Aydın Adnan Menderes University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood Caries (ECC), run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melis Akyıldız (05387970703, baharmeliss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries Risk Assessment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07330570, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.