NCT06760104

Brief Summary

This diagnostic accuracy study aims to evaluate the effectiveness of various artificial intelligence models in detecting dental plaque from intraoral images compared to clinical assessments performed by dentists among children. The study seeks to determine the accuracy, sensitivity, specificity, and overall performance of AI technologies in identifying dental plaque. study study Design: Observational study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 22, 2024

Last Update Submit

January 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of dental plaque detection

    The primary outcome measure evaluates the diagnostic accuracy of different artificial intelligence models in detecting dental plaque from intraoral images compared to clinical assessments.

    primary outcome will be assessed at Baseline Prior to any intervention, intraoral images will be captured and assessed using AI models and clinical evaluation.

Study Arms (2)

intraoral images for Children with Dental Plaque for assessment by dentist

Intervention Overview: Participants will undergo intraoral imaging using \[intraoral camera\]. Intervention Overview: A trained dentist or dental hygienist will conduct a clinical assessment of each child's dental plaque levels using standard clinical criteria. Assessment Method: The clinical assessment will involve visual inspection and may use plaque index to evaluate the amount of plaque present. Data Collection and Analysis: Outcome Measures: The results from the AI models and clinical assessments will be compared to calculate diagnostic accuracy metrics, such as sensitivity, specificity, positive predictive value, and negative predictive value.

intraoral images for Children with Dental Plaque for assessment by AI models

Intervention Overview: Participants will undergo intraoral imaging using \[intraoral camera\]. AI Models: The images will be analyzed using different AI models designed for dental plaque detection. Data Collection and Analysis: Outcome Measures: The results from the AI models and clinical assessments will be compared to calculate diagnostic accuracy metrics, such as sensitivity, specificity, positive predictive value, and negative predictive value.

Diagnostic Test: Dental Plaque Detection Using AI Models

Interventions

1. AI Model Analysis: Description: Intraoral images of participants will be captured using standardized imaging techniques. These images will then be analyzed using various artificial intelligence models specifically designed for detecting dental plaque. The AI models will process the images to identify and quantify the presence of dental plaque. 2. Clinical Assessment: Description: A qualified dentist will perform a traditional clinical examination of the participants to assess dental plaque using standard examination techniques. This will serve as the reference standard against which the AI models will be compared. Study Procedures Image Acquisition: Intraoral images will be taken of each participant using \[ intraoral camera\]. AI Model Evaluation: The captured images will be analyzed using different AI algorithms, which may include.

intraoral images for Children with Dental Plaque for assessment by AI models

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children from 7 to 12 years old.

You may qualify if:

  • Study participants: Children within age range (7-12) years old. .Teeth without metal crowns or amalgam restoration.

You may not qualify if:

  • Children with developmental enamel defects
  • Children who are unwilling to cooperate or who has mental retardation and are prohibited from having their images taken. .Children who's their legal guardians will not approve to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Cairo University

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
naemaahmed

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 6, 2025

Study Start

January 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Locations