Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: sachiko maemoto
- Phone Number: +3293324057
- Email: Sachiko.Maemoto@ugent.be
Study Locations
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Gent
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Ghent, Gent, Belgium, 9000
- Ghent University Hospital
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Contact:
- sachiko maemoto
- Phone Number: +3293324057
- Email: Sachiko.Maemoto@ugent.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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caries diagnosis visual and bitewing
caries diagnosis intra oral scan and bitewing
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caries diagnosis CBCT
take a CBCT and registration caries
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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
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plaque visual
registration plaque with visuals
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plaque color record visual
registration with plaque color record
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plaque Intra oral scan
registration plaque with intra-oral scan
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plaque color record with Intra-oral scan
registration plaque color record with intra-oral scan
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caries diagnosis fluorescence
registration caries with fluorescence of intra-oral scan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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caries diagnosis
Time Frame: one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT
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sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
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one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT
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plaque diagnosis
Time Frame: one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks
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sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis
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one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2024-0383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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