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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
65
Imaging/Scanning and recording : Ultrasonic periodontal probing per operator (10 teeth X 6 sites/teeth = 60 probing sites per operator). In addition, 2 teeth per patient will be probed with the ultrasonic probe a second time (2 teeth x 6 sites per tooth = 12 sites per patient) for intra-operator reproducibility purpose. Manual probing per operator with the OMS probe (part of the routine of care)
University hospital of Tours
Tours, France
RECRUITINGPeriodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Time frame: 20 minutes for scanning and manual probing
Tissues and structures description
Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images
Time frame: 20 minutes for scanning and manual probing(step 1)
Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
Time frame: 20 minutes for scanning and manual probing (step 1)
Manual periodontal measurements
Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized
Time frame: 20 minutes for scanning and manual probing](step 1)
Patient evaluation questionnaire
Patient subjective evaluation of the ultrasonic probing protocol (comfort)
Time frame: 20 minutes for scanning and manual probing (step 2)
Practitioner evaluation questionnaire
Practitioner subjective evaluation of the ultrasonic probing versus manual probing
Time frame: 20 minutes for scanning and manual probing (step 2)
Manual probing
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Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe
Time frame: 20 minutes for scanning and manual probing (step 2)
The ultrasonic probe measurements performance for intra- operator reproducibility
Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing
Time frame: 20 minutes for scanning and manual probing (step 2)
Duration of the two exams (Ultrasound scanning versus OMS probe)
Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer
Time frame: 20 minutes for scanning and manual probing (step 2)