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NCT Number: NCT06965387

Deep Learning for Gummy Smile Segmentation

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.

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gülenay Colak, Research Assistant

PRINCIPAL_INVESTIGATOR

Zeynep Turgut Cankaya, Associate Professor

CONTACT

[email protected]

+905333899618

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Evaluation of gummy samples using artificial intelligence

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gulenay Colak, Research Assistant

CONTACT

[email protected]

+905072637113

Zeynep Turgut Cankaya, Associate Professor

CONTACT

[email protected]

+90 5333899618

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Deep Learning-Based Evaluation of Gummy Smile: Development and Validation of a Segmentation Model

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 11, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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