NCT07759843

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
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

Study Progress85%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2025

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

April 13, 2025

Last Update Submit

August 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of AI Software

    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.

    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

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with gummy smile

You may qualify if:

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

You may not qualify if:

  • Improperly treated gummy smile cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, cairo university

Cairo, Cairo Governorate, 11251, Egypt

RECRUITING

Central Study Contacts

Hesham Ahmed Shamma, BDS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree candidate in Periodontology

Study Record Dates

First Submitted

April 13, 2025

First Posted

August 12, 2026

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations