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临床试验/NCT06965387
NCT06965387招募中不适用

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

Gazi University1 个研究点 分布在 1 个国家目标入组 1,740 人开始时间: 2025年1月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,740
试验地点
1
主要终点
Evaluation of gummy samples using artificial intelligence

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Evaluation of gummy samples using artificial intelligence

时间窗: From enrollment to the end of treatment at 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülenay Çolak

Research Assistant

Gazi University

研究点 (1)

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