Gummy SmileNCT07759843
Evaluating AI for Diagnosing and Treating Gummy Smiles: A Pilot Study
An observational study of Gummy Smile and Artifical Intelligence, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gummy Smile, Artifical Intelligence
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with gummy smile
Who may be able to join
- Properly treated gummy smile cases either surgical through crown lengthening procedure / Orthognathic Surgery or non-surgical through orthodontic treatment /Botox injection.
Who cannot join
- Improperly treated gummy smile cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, cairo university
Cairo, Cairo Governorate, 11251
About this study
Official title: Assessment of the Diagnostic Accuracy of Artificial Intelligence in Gummy Smile Diagnosis & Treatment Planning: A Pilot Study
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.
Read the 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.
- Conditions
- Gummy Smile, Artifical Intelligence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary outcome of the study is the effectiveness of the treatment planning generated by the AI software.
This metric will examine how well the software formulates treatment plans for cases of gummy smile in comparison to conventional methods used by periodontists. The effectiveness will be quantified and reported as a percentage, allowing for an assessment of the AI's ability to propose viable and successful treatment options.
By focusing on treatment planning, this outcome aims to highlight the potential of AI technology to improve clinical decision-making and patient outcomes in periodontal care
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy SmileStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Ahmed Abdelhamid Elsayed Shamma, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759843
- Sponsor's protocol ID
- 261124
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnostic Accuracy of Artificial Intelligence in Gummy Smile Diagnosis & Treatment Planning: A Pilot Study
- ClinicalTrials.gov ID
- NCT07759843
- Acronym / sponsor ID
- 261124
- Conditions
- Gummy Smile, Artifical Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with gummy smile
Key inclusion criteria (1 listed)
- Properly treated gummy smile cases either surgical through crown lengthening procedure / Orthognathic Surgery or non-surgical through orthodontic treatment /Botox injection.
Key exclusion criteria (1 listed)
- Improperly treated gummy smile cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Effectiveness of treatment planning of AI Software
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gummy Smile and Artifical Intelligence, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hesham Ahmed Shamma, BDS (+201001101704, hesham.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.