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High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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

Eligibility

Patient Inclusion Criteria :

        Age ≥ 18 years Affiliated to a social security scheme Free, informed and signed consent
        Ability for participant to comply with the requirements of the study
        Exclusion Criteria (patient):
        Surgical procedure performed in the area to be scanned Osteosynthesis material Under legal
        protection Pregnant women, breastfeeding Teeth Inclusion Criteria Minimum of 10 teeth One
        tooth from each sextant Presence of at least 1/3 of pathological sites (>4mm and/or deep
        sites >6mm)

Study details

Periodontal Diseases

NCT05809427

University Hospital, Tours

25 January 2024

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