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

Primary Purpose

Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Periodontal probing
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University hospital of ToursRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with periodental Disease

Arm Description

Imaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care)

Outcomes

Primary Outcome Measures

Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe

Secondary Outcome Measures

Tissues and structures description
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)
Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
Manual periodontal measurements
Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized
Patient evaluation questionnaire
Patient subjective evaluation of the ultrasonic probing protocol (comfort)
Practitioner evaluation questionnaire
Practitioner subjective evaluation of the ultrasonic probing versus manual probing
Manual probing
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
Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing
Duration of the two exams (Ultrasound scanning versus OMS probe)
Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer

Full Information

First Posted
March 13, 2023
Last Updated
September 19, 2023
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT05809427
Brief Title
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Acronym
Oralus2
Official Title
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with periodental Disease
Arm Type
Experimental
Arm Description
Imaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care)
Intervention Type
Device
Intervention Name(s)
Periodontal probing
Intervention Description
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)
Primary Outcome Measure Information:
Title
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Description
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Time Frame
20 minutes for scanning and manual probing
Secondary Outcome Measure Information:
Title
Tissues and structures description
Description
Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images
Time Frame
20 minutes for scanning and manual probing(step 1)
Title
Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
Description
Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)
Time Frame
20 minutes for scanning and manual probing (step 1)
Title
Manual periodontal measurements
Description
Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized
Time Frame
20 minutes for scanning and manual probing](step 1)
Title
Patient evaluation questionnaire
Description
Patient subjective evaluation of the ultrasonic probing protocol (comfort)
Time Frame
20 minutes for scanning and manual probing (step 2)
Title
Practitioner evaluation questionnaire
Description
Practitioner subjective evaluation of the ultrasonic probing versus manual probing
Time Frame
20 minutes for scanning and manual probing (step 2)
Title
Manual probing
Description
Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe
Time Frame
20 minutes for scanning and manual probing (step 2)
Title
The ultrasonic probe measurements performance for intra- operator reproducibility
Description
Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing
Time Frame
20 minutes for scanning and manual probing (step 2)
Title
Duration of the two exams (Ultrasound scanning versus OMS probe)
Description
Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer
Time Frame
20 minutes for scanning and manual probing (step 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fréderic DENIS, PR
Phone
0033247471400
Email
frederic.denis@univ-tours.fr
Facility Information:
Facility Name
University hospital of Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic DENIS, PH
Phone
0033247474747
Email
frederic.denis@univ-tours.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

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