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Recruiting NCT06965387

Deep Learning for Gummy Smile Segmentation

Observational Gummy Smile

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gummy Smile. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Evaluation of gummy samples using artificial intelligence [Time frame: From enrollment to the end of treatment at 4 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University — Ankara

Identifiers

NCT: NCT06965387 · E-77082166-604.01-881629

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗