Clinical trial NCT05809427: High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Official title: High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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)

Primary outcomes:
measure: Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
timeFrame: 20 minutes for scanning and manual probing
Secondary outcomes:
measure: Tissues and structures description
timeFrame: 20 minutes for scanning and manual probing(step 1)
measure: Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
timeFrame: 20 minutes for scanning and manual probing (step 1)
measure: Manual periodontal measurements
timeFrame: 20 minutes for scanning and manual probing](step 1)
measure: Patient evaluation questionnaire
timeFrame: 20 minutes for scanning and manual probing (step 2)
measure: Practitioner evaluation questionnaire
timeFrame: 20 minutes for scanning and manual probing (step 2)
measure: Manual probing
timeFrame: 20 minutes for scanning and manual probing (step 2)
measure: The ultrasonic probe measurements performance for intra- operator reproducibility
timeFrame: 20 minutes for scanning and manual probing (step 2)
measure: Duration of the two exams (Ultrasound scanning versus OMS probe)
timeFrame: 20 minutes for scanning and manual probing (step 2)
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital of Tours
Study officials:
References: