Periodontal Diseases
Conditions
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
Interventions
DEVICEPeriodontal probing
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)
Sponsors
University Hospital, Tours
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed