Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Tours (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05809427
Collaborator
(none)
65
Enrollment
1
Arm
7
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Periodontal probing
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe [20 min for scanning and manual probing]

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

Secondary Outcome Measures

  1. Tissues and structures description [20 min for scanning and manual probing(step 1)]

    Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images

  2. Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) [20 min for scanning and manual probing (step 1)]

    Manual probing measurements with OMS probe (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level)

  3. Manual periodontal measurements [20 min for scanning and manual probing](step 1)]

    Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized

  4. Patient evaluation questionnaire [20 min for scanning and manual probing (step 2)]

    Patient subjective evaluation of the ultrasonic probing protocol (comfort)

  5. Practitioner evaluation questionnaire [20 min for scanning and manual probing (step 2)]

    Practitioner subjective evaluation of the ultrasonic probing versus manual probing

  6. Manual probing [20 min for scanning and manual probing (step 2)]

    Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe

  7. The ultrasonic probe measurements performance for intra- operator reproducibility [20 min for scanning and manual probing (step 2)]

    Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing

  8. Duration of the two exams (Ultrasound scanning versus OMS probe) [20 min for scanning and manual probing (step 2)]

    Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT05809427
Other Study ID Numbers:
  • DR220178/ORALUS2
  • 2022-A01781-42
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontal Diseases

Study Results

No Results Posted as of Apr 12, 2023