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Completed

NCT Number: NCT05809427

High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

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

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Tours

Tours, 37000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Periodontal probing

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)

Primary outcomes

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

    Time frame: 20 minutes for scanning and manual probing

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

Secondary outcomes

  1. Tissues and structures description

    Time frame: 20 minutes 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)

    Time frame: 20 minutes 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

    Time frame: 20 minutes 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

    Time frame: 20 minutes for scanning and manual probing (step 2)

    Patient subjective evaluation of the ultrasonic probing protocol (comfort)

  5. Practitioner evaluation questionnaire

    Time frame: 20 minutes for scanning and manual probing (step 2)

    Practitioner subjective evaluation of the ultrasonic probing versus manual probing

  6. Manual probing

    Time frame: 20 minutes 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

    Time frame: 20 minutes 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)

    Time frame: 20 minutes for scanning and manual probing (step 2)

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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: Oralus2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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