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Clinical Trials/NCT07759843
NCT07759843RecruitingNot Applicable

Assessment of the Diagnostic Accuracy of Artificial Intelligence in Gummy Smile Diagnosis & Treatment Planning: A Pilot Study

Cairo University1 site in 1 country210 target enrollmentStarted: December 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
210
Locations
1
Primary Endpoint
Diagnostic Accuracy of AI Software

Study Overview

Brief Summary

Some people have a "gummy smile," where too much gum tissue shows when they smile. Doctors currently diagnose this by hand, using rulers and visual judgment. This study is testing whether a computer program using artificial intelligence (AI) can help identify and measure gummy smiles from photographs, as accurately as expert dentists do it manually.

Patients seen at Cairo University's Periodontics and Orthodontics clinics will have photos of their smile taken. Researchers will use these photos to first "teach" the AI program how to recognize and measure a gummy smile. Then, the AI will be tested on a new set of patient photos, and its measurements will be compared to measurements made by expert dentists, to see how closely they match.

The goal is to find out whether this AI tool could one day help doctors diagnose gummy smiles more quickly and consistently, which may improve care for patients.

Detailed Description

This is a diagnostic accuracy test to evaluate the accuracy of decisions made by the computer generated program in the cases of gummy smile compared to the conventional decisions made by the periodontist as a gold standard.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Properly treated gummy smile cases either surgical through crown lengthening procedure / Orthognathic Surgery or non-surgical through orthodontic treatment /Botox injection.

Exclusion Criteria

  • •Improperly treated gummy smile cases

Outcomes

Primary Outcomes

Diagnostic Accuracy of AI Software

Time Frame: During the Validation phase (Months 5-6) and Post-analytical phase (Months 7-8) of the study, when the AI model's measurements are tested against the reference standard

The primary outcome of the study is the diagnostic accuracy of the AI software. This metric will assess the ability of the software to accurately identify cases of gummy smile compared to traditional diagnostic methods. The results will be measured and reported as a percentage, providing a clear indication of the software's performance and reliability in clinical settings.

Secondary Outcomes

  • Effectiveness of treatment planning of AI Software(Months 5 through 8 of the study (Validation and Post-analytical phases), during which the AI model's measurements are compared against the reference standard)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hesham Ahmed Abdelhamid Elsayed Shamma

Master's degree candidate in Periodontology

Cairo University

Study Sites (1)

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