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White Spot Lesion of ToothNCT07639749

Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring

An observational study of White Spot Lesion of Tooth, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
White Spot Lesion of Tooth
What is being tested?
Artificial Intelligence models (YOLO and MASK-RCNN)
How many people
329 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 30 Dec 2027
How long will I take part?
1 Year
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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients attending the Conservative Department of Cairo University Dental Clinic, aged from 20 to 60 years, presenting with white spot lesions of teeth, showing no signs or symptoms, demonstrating co-operation, and expressing interest in participating in the study will be considered eligible. Patients with orthodontic appliances or bridgework that could impact the clinical assessment process will be excluded.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mohamed Hisham A.ELFattah Gabr, PhD contact

+201005660842

mohamed_gabr@dentistry.cu.edu.eg

About this study

Official title: 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?
Read the detailed description

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.

Being tested
Artificial Intelligence models (YOLO and MASK-RCNN)
Keywords
white spot lesions, dental, caries, intraoral, photography, diagnostic accuracy, artificial intelligence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Intelligence models (YOLO and MASK-RCNN)Other

    Machine learning model well be used for assessment of intraoral photographs for the detection, identification, and scoring of white spot lesions in teeth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Artificial Intelligence diagnostic accuracy in White Spot Lesions Detection

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Prospective
Enrolment
329 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639749
Sponsor's protocol ID
AI in detecting dental caries
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41487724
  • 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.

    PubMed 41696690
  • 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.

    PubMed 39947783
  • 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.

    PubMed 41538677
  • 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.

    PubMed 41068748

Questions about this trial

What is this clinical trial studying?

An observational study of White Spot Lesion of Tooth, run by Cairo University.

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 4 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Mohamed Hisham A.ELFattah Gabr, PhD (+201005660842, mohamed_gabr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Artificial Intelligence diagnostic accuracy in White Spot Lesions Detection (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 NCT07639749, which also lists 5 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 21 Oct 2026.

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