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临床试验/NCT07693322
NCT07693322已完成不适用

Development of an Artificial Intelligence-Based Clinical Image Model for Detection, Classification, and Management Recommendations of Anterior Gingival Recession

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2025年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.

研究概览

简要总结

This study aims to develop and evaluate an artificial intelligence-based clinical image model for the detection, classification, and management recommendations of anterior gingival recession. The study will utilize clinical images of patients presenting with gingival recession to train and validate a machine learning model capable of accurately identifying and classifying the condition according to established clinical criteria. In addition, the model will provide preliminary treatment recommendations based on the severity and type of recession. This is a diagnostic and model-development study designed to support clinicians in improving the accuracy and consistency of diagnosis and treatment planning for gingival recession in the anterior region.

详细描述

This study is designed to develop and validate an artificial intelligence (AI)-based clinical image analysis model for the detection, classification, and management recommendation of anterior gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, dentinal hypersensitivity, and increased risk of root caries.

Clinical intraoral images of patients presenting with anterior gingival recession will be collected following standardized imaging protocols. The dataset will be used to train, validate, and test a machine learning model capable of identifying the presence of gingival recession and classifying its severity and/or type according to established periodontal classification systems.

The AI model will also be designed to generate preliminary management recommendations based on the detected class, supporting clinical decision-making. Model performance will be evaluated using standard metrics such as accuracy, sensitivity, specificity, precision, recall, and area under the receiver operating characteristic curve (AUC-ROC).

The study is observational in nature with a diagnostic and model-development component. All patient data will be anonymized to ensure confidentiality, and ethical approval will be obtained prior to data collection. The final output is intended to support clinicians in improving diagnostic consistency and treatment planning efficiency for anterior gingival recession.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients aged 18 years or older
  • Presence of at least one anterior tooth exhibiting gingival recession classified according to the Cairo classification system (RT1, RT2, or RT3). - The gingival margin must be clearly visible.
  • High-quality images (good focus, lighting, and resolution) are required.
  • Clinically visible and intact cementoenamel junction (CEJ).

排除标准

  • Presence of cervical restorations or fixed prostheses that interfere with CEJ identification.
  • Patients undergoing active orthodontic treatment.
  • Pregnant individuals, due to hormonal changes affecting gingival tissues.
  • Images with poor photographic quality.

结局指标

主要结局

Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.

时间窗: Through study completion, an average of 6 months

-Primary Outcome 1 Outcome Measure: Sensitivity and specificity of the AI system for detecting gingival recession compared with clinical probing measurements. Primary Outcome 2 Outcome Measure: Agreement between the AI system and expert clinicians in classifying gingival recession according to the Cairo classification, assessed using Cohen's kappa coefficient.

次要结局

  • - Error in automated CEJ identification, compared to manual annotations.(Immediately after AI analysis of the clinical images)

研究者

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

Abeer Rashed Murshed

Master's Degree Candidate

Al-Azhar University

研究点 (1)

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