Clinical trial NCT06945354: Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
Official title: Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Caries (Diagnosis)
Dental Plaque (Diagnosis)
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population is selected from Ghent university hospital

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


Eligibility 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 -

Primary outcomes:
measure: caries diagnosis
timeFrame: one time measurement ( visual inspection ) 2weeks later, inspection of intra-oral scan and CBCT
measure: plaque diagnosis
timeFrame: one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent university hospital
state: Gent
Study officials:
References: