High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
研究概览
简要总结
The goal of this clinical investigation is evaluation the agreement between the periodontal pocket depth measurement obtained by periodontal probing (gold standard) and the measurement obtained by the ultrasound device
详细描述
This is a single-center prospective Clinical Investigation in two steps:
Step 1 Preliminary phase : collection and assessment of ultrasonic images to visualize dental and periodontal tissues and structures in order to manually perform periodontal measurements and generate data required for the Artificial Intelligence module training Step 2 : Performance Evaluation : assessment of the ultrasonic probe performance for faster, automatic, accurate and repeatable periodontal measurements in more comfortable conditions for both operator and patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient with periodental Disease
Imaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care)
干预措施: Periodontal probing (Device)
结局指标
主要结局
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
时间窗: 20 minutes for scanning and manual probing
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
次要结局
- Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)(20 minutes for scanning and manual probing (step 1))
- The ultrasonic probe measurements performance for intra- operator reproducibility(20 minutes for scanning and manual probing (step 2))
- Manual periodontal measurements(20 minutes for scanning and manual probing](step 1))
- Patient evaluation questionnaire(20 minutes for scanning and manual probing (step 2))
- Practitioner evaluation questionnaire(20 minutes for scanning and manual probing (step 2))
- Tissues and structures description(20 minutes for scanning and manual probing(step 1))
- Manual probing(20 minutes for scanning and manual probing (step 2))
- Duration of the two exams (Ultrasound scanning versus OMS probe)(20 minutes for scanning and manual probing (step 2))