Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries

NCT ID: NCT06945354

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-31

Brief 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. 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:

1. 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.

2. 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.

1. explanation to patients

2. take an intra-oral scan (STUDY SPECIFIC)

3. conventional visual inspection and palpation plaque scoring

4. plaque staining (record with parostatus.ch)

5. 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)

6. calculus removal and cleaning

7. take bite-wing radiographs

8. visual caries detection

9. take a thirth intra-oral scan (STUDY SPECIFIC)

10. CBCT scan (STUDY SPECIFIC)

11. plaque detection on IOS images and caries detection using IOS images and CBCT images

Conditions

Dental Caries (Diagnosis); Dental Plaque (Diagnosis)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

caries diagnosis visual and bitewing

caries diagnosis intra oral scan and bitewing

No interventions assigned to this group

caries diagnosis CBCT

take a CBCT and registration caries

No interventions assigned to this group

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

No interventions assigned to this group

plaque visual

registration plaque with visuals

No interventions assigned to this group

plaque color record visual

registration with plaque color record

No interventions assigned to this group

plaque Intra oral scan

registration plaque with intra-oral scan

No interventions assigned to this group

plaque color record with Intra-oral scan

registration plaque color record with intra-oral scan

No interventions assigned to this group

caries diagnosis fluorescence

registration caries with fluorescence of intra-oral scan

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent university hospital

Ghent, Gent, Belgium

Countries

Belgium

Central Contacts

sachiko maemoto

Role: CONTACT

Sachiko.Maemoto@ugent.be

+3293324057

Facility Contacts

sachiko maemoto

Role: primary

Sachiko.Maemoto@ugent.be

+3293324057

Other Identifiers

ONZ-2024-0383

Identifier Type: -

Identifier Source: org_study_id