- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07639749
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
Diagnostic Accuracy of Artificial Intelligence Analysis Using Intraoral Photographs Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring.
The goal of this observational study is to compare the diagnostic accuracy of Clinical examination as a standard for detection, identification and scoring of White Spot Lesions Versus Artificial intelligence analysis of intraoral photographs. The photographs are examined by experienced dental professionals to maintain diagnostic accuracy. Machine learning models YOLO and Mask-RCNN will analyze these images in three phases: pre-analytical, analytical and post-analytical. A dataset of 329 labelled photographs, annotated by experts, is used to train these models. Data augmentation methods enhance model performance, and accuracy is assessed against clinical examination results to confirm reliability.
The main question it aims to answer is:
- Is artificial intelligence analysis of intraoral photographs as accurate as clinical assessment in the detection, identification, and scoring of white spot lesions among adult Egyptian patients attending Cairo University Dental Hospital?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Dentists frequently encounter various dental hard tissue anomalies that present both diagnostic challenges and require careful treatment planning. A common example is white spot lesions or whitish discolorations of the teeth that can arise from multiple etiologies. These may be carious in nature, such as post-orthodontic incipient caries, or represent developmental defects like dental fluorosis or molar-incisor hypo-mineralization (MIH). Distinguishing between these conditions is essential for appropriate clinical management. The diagnosis of WSLs primarily relies on visual and photographic examination, which evaluates the morphology, size, color, and location of the lesions. Depth assessment is particularly critical, as it serves as a key determinant in selecting the most appropriate treatment approach. Detection and scoring of WSLs can be accomplished through clinical visual inspection alone or enhanced by adjunctive diagnostic technologies, including laser fluorescence, quantitative light-induced fluorescence (QLF), and electrical impedance spectroscopy.
The clinical characteristics of WSLs can vary considerably, making differential diagnosis challenging. While specialist clinicians demonstrate high validity and reliability in distinguishing between various white spot lesions, general dental practitioners exhibit lower diagnostic accuracy. Conventional diagnostic approaches for white spot lesions often lack precision and consistency. Visual assessment presents several inherent limitations, including the potential for misclassification due to overlapping clinical presentations among different etiologies. A systematic review and meta-analysis examining the efficacy of detection methods for incipient caries reported that photographic visual inspection achieved a sensitivity of only 67% and specificity of 79%, highlighting the need for more reliable diagnostic approaches.
Recent advances in computing power, data accessibility, and processing capabilities have accelerated the development of artificial intelligence (AI) applications, transforming contemporary healthcare research. Dentistry has similarly benefited from this technological evolution, with AI demonstrating considerable potential across various clinical applications. Machine learning (ML), a subfield of AI, represents a powerful approach for computer-aided diagnostic support, with algorithms that identify patterns within datasets during training and apply this knowledge to make predictions on new data. Emerging evidence indicates that these AI advances can improve diagnostic accuracy in caries detection, thereby supporting clinicians in making more precise and reliable assessments. Dental photography, captured using devices such as DSLR cameras or intraoral cameras, serves as a valuable tool for diagnosis and treatment planning. When combined with intelligent image analysis methods, AI can automate the identification and assessment of diagnostic data from photographs, facilitating standalone diagnostic procedures that reduce subjectivity and enhance clinical decision-making. Deep CNNs can detect and distinguish entities of similar but not identical appearance when trained on sufficiently large image datasets. Employing such models as part of an integrated image-analysis software solution would enable rapid classification of existing photographic library data and improve the accuracy and reliability of clinicians' decision-making in treatment planning or referral. Emerging evidence from studies using intraoral photographs and AI algorithms demonstrates promising detection rates, with AI exhibiting high sensitivity, specificity, precision, accuracy, and reliability in diagnostic performance. AI-driven tools are designed to serve as supportive aids for clinicians, strengthening diagnostic accuracy, streamlining workflows, improving cost-efficiency, and enhancing patient care rather than replacing clinical expertise. Simplifying the diagnostic process for white spot lesions is essential to enable their timely detection at an early stage, facilitating prompt intervention and improving preventive outcomes. AI models must be validated using local data from diverse clinical settings, particularly in lower-middle-income countries, with their performance assessed through sensitivity, specificity, and accuracy measures and benchmarked against conventional diagnostic approaches. Therefore, it is crucial to develop and validate white spot lesion detection and classification models using data from Egyptian patients attending Cairo University Hospital to ensure accurate and clinically relevant results, emphasizing the potential improvements in accuracy and reliability that AI can bring to dental diagnostics.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed Hisham A.ELFattah Gabr, PhD
- Número de teléfono: +201005660842
- Correo electrónico: mohamed_gabr@dentistry.cu.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients aged 20 - 60 years
- Males or Females
- Patients with white spot lesions of teeth 4 - Co-operative patients with interest in participation in the study
Exclusion Criteria:
- Patients with orthodontic appliances or bridgework that might interfere with evaluation and assessment
- Patients with no white spot lesions
- Patients with systematic diseases that might affect participation
- Patients refusing to sign the informed consent or not willing to be part of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Artificial Intelligence diagnostic accuracy in White Spot Lesions Detection
Periodo de tiempo: Baseline
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Asmaa A. Mohamed Yassen, Professor of Conservative Dentistry Department, Faculty of Dentistry, Cairo University
- Director de estudio: Rawda Hesham Abdelaziz, Associate Professor of Conservative Dentistry Department, Faculty of Dentistry, Cairo University
- Director de estudio: Asmaa A. Elsayed Osman, Lecturer of Information Technology, Faculty of Computers and Artificial Intelligence, Cairo University
Publicaciones y enlaces útiles
Publicaciones Generales
- Albuhayri FS, Albshaier SJ, Dashti AI, Alrajhi JF, Alhamidy FK, Busuhail MA, Bujbarah FN, Rizq MK, Thubab NA, Takronni SA, Alharbi JI, Hakami AH, Aloufi HS, Mathar MI. The Expanding Role of Artificial Intelligence in Dentistry: A Cross-Specialty Chairside Perspective. Cureus. 2025 Dec 4;17(12):e98449. doi: 10.7759/cureus.98449. eCollection 2025 Dec.
- Caldwell J, Parekh K, Crowther B, Gohel C, Pileggi R, Garcia AI, Ghorbanifarajzadeh M, Dolan TA, Gohel A. Performance evaluation of AI-based caries detection technology and its educational training module: a dual-phase investigation. Front Dent Med. 2026 Jan 29;6:1741855. doi: 10.3389/fdmed.2025.1741855. eCollection 2025.
- Abbott LP, Saikia A, Anthonappa RP. ARTIFICIAL INTELLIGENCE PLATFORMS IN DENTAL CARIES DETECTION: A SYSTEMATIC REVIEW AND META-ANALYSIS. J Evid Based Dent Pract. 2025 Mar;25(1):102077. doi: 10.1016/j.jebdp.2024.102077. Epub 2024 Dec 12.
- Noro LRA, Manzanares Cespedes MC. Artificial intelligence and oral photography: an approach to the epidemiology of dental caries. Rev Saude Publica. 2026 Jan 12;59:e53. doi: 10.11606/s1518-8787.2025059006910. eCollection 2026.
- Chung HM, Ke J, Zhang M, Kong L, Zheng J, Xiang L. Tooth-to-white spot lesion YOLO: a novel model for white spot lesion detection. BMC Oral Health. 2025 Oct 9;25(1):1577. doi: 10.1186/s12903-025-06936-w.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AI in detecting dental caries
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Artificial Intelligence models (YOLO and MASK-RCNN)
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