- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555223
Intraoral Scan and CBCT-Aided Diagnosis of Dental Plaque and Caries
April 21, 2026 updated by: University Ghent
Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
This prospective clinical study aims to evaluate the diagnostic accuracy of intraoral scans (IOS) for the detection of dental plaque and caries.
The diagnostic performance of IOS will be compared with current clinical reference standards.
For plaque assessment, IOS-based evaluation will be compared with plaque detection using disclosing agents.
For caries detection, IOS (including white-light imaging and caries detection features) will be compared with conventional visual inspection and bitewing radiography.
Adult patients aged 18 to 70 years will be included.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sachiko maemoto
- Phone Number: +32 93 32 40 57
- Email: Sachiko.Maemoto@ugent.be
Study Locations
-
-
Botestraat
-
Wondelgem, Botestraat, Belgium, 104
- Recruiting
- Tandarts Praktijk VERVACK
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adult patients aged 18 to 70 years undergoing intraoral examination in a clinical setting, with at least 20 teeth, who are not pregnant and able to provide informed consent.
Description
Inclusion Criteria:
- Adults aged 18 to 70 years
- Not pregnant and not planning pregnant
- At least 20 teeth present
- Ability to provide informed consent
Exclusion Criteria:
- Conditions that prevent proper intraoral examination (e.g., severe gag reflex, limited mouth opening)
- patient unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study Participants
All participants undergo intraoral scanning, visual inspection, plaque disclosure, and bitewing radiography for the assessment of dental plaque and caries.
|
intraoral scanning used for assessment of dental plaque and caries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Accuracy of Intraoral Scan for Dental Plaque Detection
Time Frame: At baseline and 2 weeks
|
Diagnostic accuracy of intraoral scan compared with plaque assessment using disclosing agents.
|
At baseline and 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between Intraoral Scan and Reference Standard for Dental Caries Detection
Time Frame: At baseline and 2 weeks
|
Agreement between intraoral scan assessments and reference standard (visual inspection and bitewing radiography) using kappa statistics.
|
At baseline and 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
April 21, 2026
First Posted (Actual)
April 29, 2026
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2024-0383
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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