NCT05809427

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 13, 2023

Last Update Submit

April 30, 2026

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Tissues and structures description

    20 minutes for scanning and manual probing(step 1)

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

    20 minutes for scanning and manual probing (step 1)

  • Manual periodontal measurements

    20 minutes for scanning and manual probing](step 1)

  • Patient evaluation questionnaire

    20 minutes for scanning and manual probing (step 2)

  • Practitioner evaluation questionnaire

    20 minutes for scanning and manual probing (step 2)

  • +3 more secondary outcomes

Study Arms (1)

Patient with periodental Disease

EXPERIMENTAL

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

Interventions

Periodontal probingDEVICE

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)

Patient with periodental Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Tours

Tours, 37000, France

Location

Related Publications (4)

  • Renaud M, Delpierre A, Becquet H, Mahalli R, Savard G, Micheneau P, Carayon D, Denis F. Intraoral Ultrasonography for Periodontal Tissue Exploration: A Review. Diagnostics (Basel). 2023 Jan 18;13(3):365. doi: 10.3390/diagnostics13030365.

    PMID: 36766470RESULT

  • Rochefort GY, Denis F, Renaud M. Ultrasound Imaging: Advancing the Diagnosis of Periodontal Disease. Dent J (Basel). 2025 Jul 29;13(8):349. doi: 10.3390/dj13080349.

    PMID: 40863052RESULT

  • Renaud M, Gette M, Delpierre A, Calle S, Levassort F, Denis F, Rochefort GY. Intraoral Ultrasonography for the Exploration of Periodontal Tissues: A Technological Leap for Oral Diagnosis. Diagnostics (Basel). 2024 Jun 24;14(13):1335. doi: 10.3390/diagnostics14131335.

    PMID: 39001225RESULT

  • Estrade L, Delpierre A, Rimbaud V, Denis F, Rochefort GY, Renaud M. High-frequency intraoral ultrasonography for periodontal tissue characterization: a pilot study exploring echogenic signatures and inflammation detection. BMC Oral Health. 2025 Dec 11;26(1):97. doi: 10.1186/s12903-025-07485-y.

    PMID: 41372763RESULT

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 12, 2023

Study Start

July 7, 2023

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)