NCT05809427

High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	Periodontal 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)

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-04-12
• Last updated: 2023-09-21

Locations

1 site across 1 country: France