High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
- Conditions
- Periodontal Diseases
- Interventions
- Device: Periodontal probing
- Registration Number
- NCT05809427
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient with periodental Disease Periodontal probing Imaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care)
- Primary Outcome Measures
Name Time Method Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe 20 minutes for scanning and manual probing Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
- Secondary Outcome Measures
Name Time Method Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) 20 minutes for scanning and manual probing (step 1) Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
The ultrasonic probe measurements performance for intra- operator reproducibility 20 minutes for scanning and manual probing (step 2) Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing
Manual periodontal measurements 20 minutes for scanning and manual probing](step 1) Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized
Patient evaluation questionnaire 20 minutes for scanning and manual probing (step 2) Patient subjective evaluation of the ultrasonic probing protocol (comfort)
Practitioner evaluation questionnaire 20 minutes for scanning and manual probing (step 2) Practitioner subjective evaluation of the ultrasonic probing versus manual probing
Tissues and structures description 20 minutes for scanning and manual probing(step 1) Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images
Manual probing 20 minutes for scanning and manual probing (step 2) Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe
Duration of the two exams (Ultrasound scanning versus OMS probe) 20 minutes for scanning and manual probing (step 2) Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer
Trial Locations
- Locations (1)
University hospital of Tours
🇫🇷Tours, France