Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809427
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-03-13
Brief Title:
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oralus2
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01781-42 | OTHER | IDRCB | None |