High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

NCT ID: NCT05809427

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-07

Study Completion Date

2024-05-31

Brief Summary

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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

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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

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Periodontal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Periodontal probing

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital of Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fréderic DENIS, PR

Role: CONTACT

0033247471400

Facility Contacts

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Frederic DENIS, PH

Role: primary

0033247474747

Other Identifiers

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2022-A01781-42

Identifier Type: OTHER

Identifier Source: secondary_id

DR220178/ORALUS2

Identifier Type: -

Identifier Source: org_study_id

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