High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases (Oralus2)

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

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: Periodontal probing

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

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fréderic DENIS, PR; Phone Number: 0033247471400; Email: frederic.denis@univ-tours.fr

Study Locations

• France
  • Tours, France, 37000
    • Recruiting
    • University Hospital of Tours
    • Contact: Frederic DENIS, PH; Phone Number: 0033247474747; Email: frederic.denis@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient with periodental Disease; 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; 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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: DR220178/ORALUS2; 2022-A01781-42 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No