- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07693322
Development of an Artificial Intelligence-Based Clinical Image Model for Detection, Classification, and Management Recommendations of Anterior Gingival Recession
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Cairo, 이집트
- Faculty of Dental Medicine for Girls, Al-Azhar University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Gingival Recession Patients
This group consists of patients presenting with anterior gingival recession.
Clinical intraoral images will be collected from eligible participants and used for the development and validation of an artificial intelligence-based classification model.
The dataset includes cases with varying degrees and types of gingival recession according to established clinical classification criteria.
No therapeutic intervention will be performed as part of the study, and all images will be analyzed for diagnostic and classification purposes only.
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An artificial intelligence-based clinical image model will be developed and evaluated using standardized clinical photographs of anterior teeth presenting with gingival recession.
The model will be trained to detect the presence of gingival recession, classify lesions according to the Cairo classification system (RT1, RT2, and RT3), and generate preliminary management recommendations based on the identified classification.
The system's performance will be assessed by comparing its diagnostic and classification outputs with expert clinical assessments.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.
기간: Through study completion, an average of 6 months
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-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. |
Through study completion, an average of 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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- Error in automated CEJ identification, compared to manual annotations.
기간: Immediately after AI analysis of the clinical images
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Immediately after AI analysis of the clinical images
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .