NCT07639749

Brief 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. 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?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

white spot lesionsdentalcariesintraoralphotographydiagnostic accuracyartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Artificial Intelligence diagnostic accuracy in White Spot Lesions Detection

    Baseline

Interventions

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 41487724BACKGROUND
  • 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.

    PMID: 41696690BACKGROUND
  • 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.

    PMID: 39947783BACKGROUND
  • 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.

    PMID: 41538677BACKGROUND
  • 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.

Study Officials

  • Asmaa A. Mohamed Yassen

    Professor of Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR
  • Rawda Hesham Abdelaziz

    Associate Professor of Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    STUDY DIRECTOR
  • Asmaa A. Elsayed Osman

    Lecturer of Information Technology, Faculty of Computers and Artificial Intelligence, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mohamed Hisham A.ELFattah Gabr, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06