High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

Periodontal Diseases Clinical Trial

— Oralus2  

Official title:

High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809427
• Other study ID #: DR220178/ORALUS2
• Secondary ID: 2022-A01781-42
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: May 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Tours
• Contact: Fréderic DENIS, PR
• Phone: 0033247471400
• Email: frederic.denis[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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)

Locations

Country	Name	City	State
France	University hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Patient evaluation questionnaire	Patient subjective evaluation of the ultrasonic probing protocol (comfort)	20 minutes for scanning and manual probing (step 2)
Secondary	Practitioner evaluation questionnaire	Practitioner subjective evaluation of the ultrasonic probing versus manual probing	20 minutes for scanning and manual probing (step 2)
Secondary	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)
Secondary	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)
Secondary	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)