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Aún no reclutaNCT07929753Registro de ClinicalTrials.gov

AI-Based Caries and Plaque Detection and Caries Risk Prediction in Children

Dental Caries · Caries Risk · Dental Plaque

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
4 años - 13 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
250 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This study aims to develop and evaluate an artificial intelligence (AI)-based system that can detect dental caries and dental plaque in children using intraoral digital scans and photographs, and use these findings to estimate each child's risk of developing dental caries.

Children aged 4-13 years who attend Marmara University Faculty of Dentistry, Department of Pediatric Dentistry for routine dental care will be invited to participate. Participants will receive a clinical dental examination. Dental caries will be evaluated using standard clinical criteria, and dental plaque will be assessed using a plaque index. Intraoral photographs and three-dimensional digital scans of the teeth will also be obtained. Parents will complete a questionnaire about their child's toothbrushing habits, sugar consumption, fluoride use, dental visits, and selected sociodemographic factors.

The collected digital images and scans will be used to train and test an AI model designed to automatically identify and measure areas of dental caries and plaque. The AI findings will then be combined with clinical examination results and oral health-related information to classify children as having low, moderate, or high caries risk.

Based on the assigned caries risk level, individualized preventive recommendations such as oral hygiene instruction, dietary counseling, fluoride applications, professional plaque control, and follow-up visits will be provided. Participants will be followed according to their risk level and digital scans and clinical assessments will be repeated to evaluate changes in caries, plaque, and caries risk over time.

The study is expected to provide information on whether AI-assisted digital imaging can support more objective, standardized and personalized caries risk assessment and preventive dental care in children.

Leer la descripción completa

Dental caries is a multifactorial disease, and accurate assessment of both current disease status and future caries risk is important for planning individualized preventive care. Conventional caries risk assessment relies on the combined evaluation of clinical findings, oral hygiene, dietary habits, fluoride exposure, previous caries experience, and other risk or protective factors. However, this process may vary between clinicians and may be influenced by subjective interpretation. The present study is designed to investigate whether artificial intelligence (AI)-assisted analysis of digital dental images can contribute to a more objective, standardized, and reproducible approach to caries and dental plaque assessment in children.

Clinical dental examinations will be performed using standardized criteria. Dental caries will be recorded according to ICDAS II criteria, caries experience will be documented using DMFT/dft indices, and dental plaque will be assessed using a standardized plaque index. In addition, standardized intraoral photographs and three-dimensional intraoral digital scans will be obtained. Information related to oral health behaviors, including toothbrushing frequency, sugar consumption, fluoride exposure, and dental attendance, will be collected through a structured parental questionnaire.

The digital data will be used to develop an AI-based image analysis system for the automatic detection and segmentation of dental caries and plaque. An instance-segmentation approach is planned so that both localized carious lesions and irregularly distributed plaque areas can be identified at the pixel level rather than only by bounding boxes. The model will be developed using transfer learning from pretrained weights and will be retrained using the intraoral image and scan dataset generated within the study.

Reference annotations for model development will be created manually according to predefined clinical criteria. The annotated dataset will be divided into training, validation, and test subsets. Model performance will be evaluated using detection and segmentation metrics such as precision, recall, F1-score, mean average precision, Dice coefficient, and Intersection over Union. Additional validation procedures, including cross-validation and comparison of different convolutional approaches, are planned to improve model robustness and generalizability. Visualization methods such as Grad-CAM will also be used to improve the clinical interpretability of model decisions.

After model training and testing, the optimized system will be integrated into a clinical decision-support interface. For newly evaluated participants, intraoral scan data, with photographs when necessary, will be analyzed automatically. The system will provide outputs including the number, location, and severity of detected carious lesions and the estimated extent of dental plaque. These AI-derived findings will be combined with clinical indices and behavioral information to generate an individualized caries risk assessment.

Participants will be classified into predefined caries-risk categories using a combination of clinical disease indicators, plaque findings, AI-derived lesion and plaque measurements, and behavioral risk and protective factors. The resulting risk classification will be used to support individualized preventive recommendations. Repeated clinical and digital evaluations will allow changes in caries findings, plaque levels, and risk status to be assessed over time.

The study is intended to determine whether combining AI-based analysis of intraoral digital data with established clinical and behavioral indicators can improve the consistency and clinical usefulness of caries risk assessment in pediatric dentistry. The proposed system is intended as a clinical decision-support tool rather than a replacement for professional dental examination and judgment.

¿Quién podría participar?

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Inclusion Criteria:

  • Systemically healthy children aged 4-13 years.
  • Patients showing positive cooperation according to the Frankl Behavior Rating Scale (Frankl 3-4).
  • Patients whose legal guardian provides consent.

Exclusion Criteria:

  • Children with special health care needs.
  • Children who refuse treatment due to cooperation problems (Frankl 1-2).
  • Patients using fixed orthodontic appliances.

Población del estudio

The study population will consist of children aged 4-13 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry for routine dental care and meeting the study eligibility criteria.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
low caries risk group

Children classified as low caries risk, with no disease indicators, no or minimal risk factors, and predominant protective factors. This group includes children with no AI-detected lesion, plaque percentage \<10% or plaque index 0, twice-daily brushing with fluoride toothpaste, low sugar consumption, and regular dental attendance. Preventive recommendations will include recall every 6 months, brushing twice daily with fluoride toothpaste, dietary counseling, and fissure sealants when indicated.

Behavioral: individualized preventive recommendations

Moderate Caries Risk Group

Children without disease indicators but with at least one risk factor, including a single AI-detected non-cavitated lesion, plaque percentage of 10-29% or plaque index 1-2, increased daily sugar consumption, brushing less than twice daily, irregular dental attendance, or low fluoride exposure. Preventive recommendations will include recall every 3-6 months, oral hygiene instruction, fluoride support when needed, brushing twice daily with fluoride toothpaste, professional fluoride varnish every 6 months, dietary counseling, and fissure sealants.

Behavioral: individualized preventive recommendations

High Caries Risk Group

Children classified as high caries risk based on the presence of at least one disease indicator or increased disease burden, including ICDAS ≥3, DMFT/dft \>0, restoration or tooth loss due to caries within the previous 12 months, ≥2 AI-detected lesions, AI-detected lesion with plaque percentage ≥30%, or plaque index ≥2. Preventive recommendations will include recall every 1-3 months, professional plaque control, recommendation of a remineralizing agent (Tooth Mousse or R.O.C.S. Medical Minerals gel), oral hygiene instruction, brushing twice daily with fluoride toothpaste, professional fluoride varnish every 3 months, dietary counseling, and fissure sealants.

Behavioral: individualized preventive recommendations

individualized preventive recommendations BEHAVIORAL

Participants will be classified into predefined caries-risk categories using a combination of clinical disease indicators, plaque findings, AI-derived lesion and plaque measurements, and behavioral risk and protective factors. Based on the assigned caries risk level, individualized preventive recommendations such as oral hygiene instruction, dietary counseling, fluoride applications, professional plaque control, and follow-up visits will be provided. Participants will be followed according to their risk level, and digital scans and clinical assessments will be repeated to evaluate changes in caries, plaque, and caries risk over time.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Accuracy of the Artificial Intelligence Model for Dental Caries Detection

Plazo: Baseline

Accuracy will be calculated as the proportion of correct predictions among all evaluated predictions, using expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental caries. Accuracy will be reported as a single percentage value (%).

Sensitivity of the Artificial Intelligence Model for Dental Caries Detection

Plazo: Baseline

Sensitivity will be calculated as the proportion of correctly identified positive findings among all positive findings in the expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental caries. Sensitivity will be reported as a single percentage value (%).

Specificity of the Artificial Intelligence Model for Dental Caries Detection

Plazo: Baseline

Specificity will be calculated as the proportion of correctly identified negative findings among all negative findings in the expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental caries. Sensitivity will be reported as a single percentage value (%).

Precision of the Artificial Intelligence Model for Dental Caries Detection

Plazo: Baselina

Precision will be calculated as the proportion of correct positive predictions among all positive predictions made by the artificial intelligence model. Model predictions will be compared with manually annotated reference data for dental caries. Precision will be reported as a single percentage value (%).

F1-Score for Dental Caries Detection

Plazo: Baseline

The F1-score will be calculated as the harmonic mean of precision and recall. Values range from 0 to 1, with higher values indicating better detection performance. Model predictions will be compared with manually annotated reference data for dental caries. The F1-score will be reported as a single percentage value (%).

Intersection over Union (IoU) of the Artificial Intelligence Model for Dental Caries Segmentation

Plazo: Baseline

Intersection over Union (IoU) will be calculated as the ratio of the overlapping area to the combined area of the predicted and expert-annotated segmentation masks. Values range from 0 to 1, with higher values indicating better segmentation performance. Model predictions will be compared with manually annotated reference data for dental caries.

Accuracy of the artificial intelligence model for dental plaque detection

Plazo: Baseline

Accuracy will be calculated as the proportion of correct predictions among all evaluated predictions, using expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental plaque.

Sensitivity of the Artificial Intelligence Model for Dental Plaque Detection

Plazo: Baseline

Sensitivity will be calculated as the proportion of correctly identified positive findings among all positive findings in the expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental plaque.

Specificity of the Artificial Intelligence Model for Dental Plaque Detection

Plazo: Baseline

Specificity will be calculated as the proportion of correctly identified negative findings among all negative findings in the expert-annotated reference data. Model predictions will be compared with manually annotated reference data for dental plaque.

Precision of the Artificial Intelligence Model for Dental Plaque Detection

Plazo: Baseline

Precision will be calculated as the proportion of correct positive predictions among all positive predictions made by the artificial intelligence model. Model predictions will be compared with manually annotated reference data for dental plaque.

F1-Score of the Artificial Intelligence Model for Dental Caries Detection

Plazo: Baseline

The F1-score will be calculated as the harmonic mean of precision and recall. Values range from 0 to 1, with higher values indicating better detection performance. Model predictions will be compared with manually annotated reference data for dental plaque.

Intersection over Union (IoU) of the Artificial Intelligence Model for Dental Plaque Segmentation

Plazo: Baseline

Intersection over Union (IoU) will be calculated as the ratio of the overlapping area to the combined area of the predicted and expert-annotated segmentation masks. Values range from 0 to 1, with higher values indicating better segmentation performance. Model predictions will be compared with manually annotated reference data for dental plaque.

Medidas secundarias

AI-integrated caries risk classification

Plazo: At baseline assessment.

Participants will be classified into low, moderate, or high caries risk categories according to predefined AI-integrated criteria, combining AI-derived dental caries and plaque findings with clinical indices and behavioral risk factors. The outcome will be reported as the number of participants in each risk category.

Change in Number of Carious Lesions During Follow-up

Plazo: Baseline and up to 6 months

The number of carious lesions will be assessed at baseline and follow-up using clinical examinations and digital intraoral images. The change will be calculated by subtracting the baseline number of carious lesions from the follow-up number for each participant. Follow-up assessments will be performed according to the participant's caries risk category.

Change in Dental Plaque Percentage During Follow-up

Plazo: Baseline and up to 6 months

The change in the percentage of tooth surface area covered by dental plaque from baseline to follow-up will be evaluated using digital intraoral images and the artificial intelligence model. Follow-up assessments will be performed according to the participant's caries risk category.

Change in Caries Risk Category During Follow-up

Plazo: Baseline and up to 6 months

Changes in caries risk classification from baseline to follow-up will be evaluated using the predefined low, moderate, and high caries risk categories. The outcome will be reported as the number of participants whose risk category changes during follow-up.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

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1 centros

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği FakültesiIstanbul, Maltepe, Turkey (Türkiye)Estado desconocido

Equipo y fechas

Patrocinador principal
Marmara University
Inicio del estudio
10 ene 2027 Estimado
Finalización primaria
10 dic 2027 Estimado
Finalización del estudio
30 ene 2028 Estimado
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Detection of Dental Caries and Plaque Using AI-Based Imaging and Prediction of Caries Risk in Children

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026