Dental Caries (Diagnosis)NCT06945354
Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
An observational study of Dental Caries (Diagnosis) and Dental Plaque (Diagnosis), run by University Ghent at 1 site in Belgium.
Trial summary
In this prospective controlled trial, patients will be enrolled at the University Hospital Ghent. Inclusion criteria are: age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface. All participants have to sign an informed consent. Pregnant women will be excluded. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Caries (Diagnosis), Dental Plaque (Diagnosis)
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2025to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study population is selected from Ghent university hospital
Inclusion Criteria:age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface -
Exclusion Criteria:Pregnant women will be excluded -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Ghent university hospital
Ghent, Gent, 9000
sachiko maemoto, +3293324057, Sachiko.Maemoto@ugent.be
About this study
In this prospective controlled trial, patients will be enrolled at the University Hospital Ghent. Inclusion criteria are: age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface. All participants have to sign an informed consent. Pregnant women will be excluded. First an intra-oral scan will be taken for visual plaque detection. Thereafter, plaque scores will be noted after visual inspection and with plaque staining. After supra-gingival calculus removal and oral hygiene instructions bite-wing radiographs will be taken and a visual caries inspection will be performed. Finally, a new intra-oral scan will be taken for visual caries detection, followed by a CBCT scan.
Minimally 2 weeks after this intervention, plaque-scores and caries-scores will be measured by an independent researcher and the same researcher on the intra-oral scans, CBCT and radiographs(Pictures taken with X-rays to view the inside of your teeth and jawbone)(for caries detection).
Read more
The following variables will be measured:
- Plaque measurement: 1) Plaque detection using intra-oral scan images (white light (and fluorescence)) will be performed and compared with 2) the assessment of visual plaque detection and 3) using plaque staining (golden standard). The findings will be recorded in a plaque status through the website www.parodontalstatus. And exported to be attached to the anonymized patient file.
- Caries: The results of caries detection by intra-oral scan and bite-wing radiographs will be compared with the results of clinical caries detection and bite-wing radiographs on one hand and the CBCT images on the other hand. ICDAS scores will be registered for the visual assessment, CBCT and bite-wing radiograph images assessment.
The following step-by-step protocol will be used:
The digital data, including images, that will be the subject of the research will be acquired using 3SHAPE's Trios 5 intra-oral scan. The CBCT image will be made with the ProMax 3D of Planmeca. These two imaging techniques will be the only study specific handeling during the study.
- explanation to patients
- take an intra-oral scan (STUDY SPECIFIC)
- conventional visual inspection and palpation plaque scoring
- plaque staining (record with parostatus.ch)
- take an intra-oral scan with plaque staining in a situation that is viewed on site, in the mouth, without removing or moving anything.(STUDY SPECIFIC)
- calculus removal and cleaning
- take bite-wing radiographs
- visual caries detection
- take a thirth intra-oral scan (STUDY SPECIFIC)
- CBCT scan (STUDY SPECIFIC)
- plaque detection on IOS images and caries detection using IOS images and CBCT images
- Medical subject headings
- Dental Caries, Disease, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| caries diagnosis visual and bitewing | caries diagnosis intra oral scan and bitewing | |
| caries diagnosis CBCT | take a CBCT and registration caries | |
| Intra oral scan and bitewing | An intra-oral scan and bitewings are taken and 2 weeks later, caries is registered on the basis of this intra oral scan and bitewings | |
| plaque visual | registration plaque with visuals | |
| plaque color record visual | registration with plaque color record | |
| plaque Intra oral scan | registration plaque with intra-oral scan | |
| plaque color record with Intra-oral scan | registration plaque color record with intra-oral scan | |
| caries diagnosis fluorescence | registration caries with fluorescence of intra-oral scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries diagnosis
sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
Measured: one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT
plaque diagnosis
sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
Measured: one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945354
- Sponsor's protocol ID
- ONZ-2024-0383
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
- ClinicalTrials.gov ID
- NCT06945354
- Acronym / sponsor ID
- ONZ-2024-0383
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2025 (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.
In this prospective controlled trial, patients will be enrolled at the University Hospital Ghent. Inclusion criteria are: age between 18 and 70 years old, presence of 20 or more teeth, and have a minimum one carious tooth surface. All participants have to sign an informed consent. Pregnant women will be excluded. First an intra-oral scan will be taken for visual plaque detection. Thereafter, plaque scores will be noted after visual inspection and with plaque staining. After supra-gingival calculus removal and oral hygiene instructions bite-wing radiographs will be taken and a visual caries inspection will be performed. Finally, a new intra-oral scan will be taken for visual caries detection, followed by a CBCT scan.
Minimally 2 weeks after this intervention, plaque-scores and caries-scores will be measured by an independent researcher and the same researcher on the intra-oral scans, CBCT and radiographs(Pictures taken with X-rays to view the inside of your teeth and jawbone)(for caries detection).
The following variables will be measured:
- Plaque measurement: 1) Plaque detection using intra-oral scan images (white light (and fluorescence)) will be performed and compared with 2) the assessment of visual plaque detection and 3) using plaque staining (golden standard). The findings will be recorded in a plaque status through the website www.parodontalstatus. And exported to be attached to the anonymized patient file.
- Caries: The results of caries detection by intra-oral scan and bite-wing radiographs will be compared with the results of clinical caries detection and bite-wing radiographs on one hand and the CBCT images on the other hand. ICDAS scores will be registered for the visual assessment, CBCT and bite-wing radiograph images assessment.
The following step-by-step protocol will be used:
The digital data, including images, that will be the subject of the research will be acquired using 3SHAPE's Trios 5 intra-oral scan. The CBCT image will be made with the ProMax 3D of Planmeca. These two imaging techniques will be the only study specific handeling during the study.
- explanation to patients
- take an intra-oral scan (STUDY SPECIFIC)
- conventional visual inspection and palpation plaque scoring
- plaque staining (record with parostatus.ch)
- take an intra-oral scan with plaque staining in a situation that is viewed on site, in the mouth, without removing or moving anything.(STUDY SPECIFIC)
- calculus removal and cleaning
- take bite-wing radiographs
- visual caries detection
- take a thirth intra-oral scan (STUDY SPECIFIC)
- CBCT scan (STUDY SPECIFIC)
- plaque detection on IOS images and caries detection using IOS images and CBCT images
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| caries diagnosis visual and bitewing | – | –caries diagnosis intra oral scan and bitewing |
| caries diagnosis CBCT | – | –take a CBCT and registration caries |
| Intra oral scan and bitewing | – | –An intra-oral scan and bitewings are taken and 2 weeks later, caries is registered on the basis of this intra oral scan and bitewings |
| plaque visual | – | –registration plaque with visuals |
| plaque color record visual | – | –registration with plaque color record |
| plaque Intra oral scan | – | –registration plaque with intra-oral scan |
| plaque color record with Intra-oral scan | – | –registration plaque color record with intra-oral scan |
| caries diagnosis fluorescence | – | –registration caries with fluorescence of intra-oral scan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study population is selected from Ghent university hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
caries diagnosis
Time frame: one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT
sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
plaque diagnosis
Time frame: one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks
sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries (Diagnosis) and Dental Plaque (Diagnosis), run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 25 Apr 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sachiko maemoto (+3293324057, Sachiko.Maemoto@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries diagnosis (time frame: one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2025.