Periodontal DiseasesOralus2NCT05809427
High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
A study testing Periodontal probing in people with Periodontal Diseases, run by University Hospital, Tours at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Periodontal probing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2023to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Periodontal Diseases
- Being tested
- Periodontal probing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Periodontal probing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe
Measured: 20 minutes for scanning and manual probing
Secondary outcomes (8)
Tissues and structures description
Tissues and structures (alveolar bone, cementum, CEJ, gingiva, enamel) segmentation/labeling and visual identifications on the obtained ultrasonic images
Measured: 20 minutes for scanning and manual probing(step 1)
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)
Measured: 20 minutes for scanning and manual probing (step 1)
Manual periodontal measurements
Manunual periodontal measurements (Periodontal pocket depth, Gingival Margin, Clinical Attachment Level) on the ultrasonic images collected and visualized
Measured: 20 minutes for scanning and manual probing](step 1)
Patient evaluation questionnaire
Patient subjective evaluation of the ultrasonic probing protocol (comfort)
Measured: 20 minutes for scanning and manual probing (step 2)
Practitioner evaluation questionnaire
Practitioner subjective evaluation of the ultrasonic probing versus manual probing
Measured: 20 minutes for scanning and manual probing (step 2)
Manual probing
Manual probing with the OMS probe versus Artificial Intelligence (AI) measurements obtained with the ultrasonic probe
Measured: 20 minutes for scanning and manual probing (step 2)
The ultrasonic probe measurements performance for intra- operator reproducibility
Evaluation of the intra-operator reproducibility of the measurements made during ultrasonic probing
Measured: 20 minutes for scanning and manual probing (step 2)
Duration of the two exams (Ultrasound scanning versus OMS probe)
Evaluation of duration of ultrasound scanning and duration of manual probing using a chronometer
Measured: 20 minutes for scanning and manual probing (step 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start7 Jul 2023
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809427
- Sponsor's protocol ID
- DR220178/ORALUS2
- Other IDs
- 2022-A01781-42
- Acronym
- Oralus2
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36766470Rochefort 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.
PubMed 40863052Renaud 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.
PubMed 39001225Estrade 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.
PubMed 41372763
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases
- ClinicalTrials.gov ID
- NCT05809427
- Acronym / sponsor ID
- Oralus2 / DR220178/ORALUS2
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with periodental Disease | Experimental | Device: Periodontal probingImaging/Scanning and recording by Ultrasonic periodontal probing per operator Manual probing per operator with the OMS probe (part of the routine of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal probingImaging/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) | Device | Patient with periodental Disease |
Primary outcome
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
8 secondary outcomes
Tissues and structures description
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)
Time frame: 20 minutes for scanning and manual probing (step 1)
Manual periodontal measurements
Time frame: 20 minutes for scanning and manual probing](step 1)
Patient evaluation questionnaire
Time frame: 20 minutes for scanning and manual probing (step 2)
Practitioner evaluation questionnaire
Time frame: 20 minutes for scanning and manual probing (step 2)
Manual probing
Time frame: 20 minutes for scanning and manual probing (step 2)
The ultrasonic probe measurements performance for intra- operator reproducibility
Time frame: 20 minutes for scanning and manual probing (step 2)
Duration of the two exams (Ultrasound scanning versus OMS probe)
Time frame: 20 minutes for scanning and manual probing (step 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 36766470Renaud 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.
- Results publication: PubMed 40863052Rochefort 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.
- Results publication: PubMed 39001225Renaud 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.
- Results publication: PubMed 41372763Estrade 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal probing in people with Periodontal Diseases, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depth measurement by manual probing and measurement by ultrasound probe (time frame: 20 minutes for scanning and manual probing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809427, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.