High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

Study Overview
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Brief Summary
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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
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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

Official Title
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High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Device: Periodontal probing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with periodental Disease<br>Imaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care) | Device: Periodontal probing<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe | Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe | 20 minutes for scanning and manual probing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissues and structures description | Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images | 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) | 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 | 20 minutes for scanning and manual probing](step 1) | 
| Patient evaluation questionnaire | Patient subjective evaluation of the ultrasonic probing protocol (comfort) | 20 minutes for scanning and manual probing (step 2) | 
| Practitioner evaluation questionnaire | Practitioner subjective evaluation of the ultrasonic probing versus manual probing | 20 minutes for scanning and manual probing (step 2) | 
| Manual probing | Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe | 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 | 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 | 20 minutes for scanning and manual probing (step 2) |