ClinicalTrials.gg
RecruitingNCT06965387Updated May 21, 2025

Deep Learning for Gummy Smile Segmentation

An observational study in Gummy Smile, sponsored by Gazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Gazi University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,740
Ages
12 Years and older
Sex
All
01

Study summary

A gummy smile (excessive visibility of the gums when smiling) is not merely an aesthetic issue but also an important parameter in terms of periodontal health. Current evaluation methods are subjective and non-standardized, leading to limitations in both clinical accuracy and patient communication. In recent years, AI-based models have begun to be effectively used in dental image analysis and diagnostic processes. This study aims to develop an AI-supported objective and reproducible analysis model capable of evaluating gummy smile from both aesthetic and periodontal perspectives using a unique dataset composed of images obtained through standard clinical protocols and labeled by the same expert.

Individuals aged 12 years or older with no maxillary anterior (teeth #13-23) tooth loss will be included in the study. Patients with missing anterior maxillary teeth (teeth #13-23), significant anatomical pathologies, or smile-interfering factors (e.g., facial piercings, orthodontic appliances, facial hair) will be excluded.

Standardized frontal photographs will be taken using a single device (iPhone 15) to ensure consistency in resolution, lighting, and color balance. Images will be captured from a fixed distance of 15 cm with participants in an upright position, eyes facing forward, and heads aligned to the Frankfurt Horizontal Plane. To maintain standardization, the smartphone's grid lines will be used to align the horizontal line with the pupils and vertical lines with the nasal alae.

Images of high, average, and low smile lines will be labeled by a periodontist using the web-based annotation tool MakeSense. Visible gingival areas will be annotated as polygons bounded superiorly by the lower border of the upper lip and inferiorly by the gingival margin. For participants with high smile lines, gingival display will be measured using ImageJ (National Institutes of Health, Bethesda, MD, USA), with calibration performed via a periodontal probe embedded in each photo. A pixel-to-millimeter conversion factor will be derived and applied to measurements between the upper lip and gingival margin in the anterior maxillary sextant (teeth #13-23). Distances between paired landmarks (points 7-13, 8-14, 9-15, 10-16, 11-17, 12-18) will be measured in millimeters. AI-based segmentation outputs (via MakeSense) will be statistically compared to ImageJ measurements to assess correlation.

02

Conditions studied

  • Gummy Smile
03

In context

Lead sponsor

Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who presented to the Department of Periodontology, Faculty of Dentistry, Gazi University, for routine dental evaluation and treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 12 years or older with no maxillary anterior (teeth #13-23) tooth loss will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with missing anterior maxillary teeth (teeth #13-23), significant anatomical pathologies, or smile-interfering factors (e.g., facial piercings, orthodontic appliances, facial hair) will be excluded.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,740 participants (estimated)
Patient registry
No

Groups and cohorts

  • • High smile

    Gingival margins and cervical areas are clearly visible above the upper lip line.

06

What researchers measure

Primary outcomes

  1. Evaluation of gummy samples using artificial intelligence

    Time frame: From enrollment to the end of treatment at 4 months

07

Study locations

1 of 1 sites recruiting
  • Gazi University
    Ankara, Cankaya 06490, Turkey (Türkiye)
    • Zeynep Turgut Cankaya, Associate Professor · Contact · zeynepturgut@gazi.edu.tr · +905333899618
    • Gülenay Colak, Research Assistant · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for May 2025, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2025
First posted
May 11, 2025
StartActual
Jan 12, 2025
Primary completionEst.
May 15, 2025
CompletionEst.
May 20, 2025
Last update
May 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06965387
Lead sponsor
Gazi University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Gülenay Çolak (Research Assistant, Gazi University) — Principal investigator
First posted
May 11, 2025
Start date
Jan 12, 2025
Primary completion
May 15, 2025 (estimated)
Completion
May 20, 2025 (estimated)
Last update
May 21, 2025

Study contacts

Zeynep Turgut Cankaya, Associate Professor
Contact
zeynepturgut@gazi.edu.tr
+90 5333899618
Gulenay Colak, Research Assistant
Contact
gulenaycolak@gazi.edu.tr
+905072637113
Zeynep Turgut Cankaya, Associate Professor
study director · Gazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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