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

NCT06945354 | Not Yet Recruiting

• 1 other identifier: ONZ-2024-0383
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.explanation to patients
4. 4.take an intra-oral scan (STUDY SPECIFIC)
5. 5.conventional visual inspection and palpation plaque scoring
6. 6.plaque staining (record with parostatus.ch)
7. 7.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)
8. 8.calculus removal and cleaning
9. 9.take bite-wing radiographs
10. 10.visual caries detection
11. 11.take a thirth intra-oral scan (STUDY SPECIFIC)
12. 12.CBCT scan (STUDY SPECIFIC)
13. 13.plaque detection on IOS images and caries detection using IOS images and CBCT images

Conditions

Dental Caries (Diagnosis); Dental Plaque (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• caries diagnosis

  sensitivity specificity and area-under-curve values will be determined using receiver operating characteristic curve analysis

  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

  one time measurement ( visual inspection) and 2 weeks later inspection of intra-oral scan and 2 weeks

Study Arms (8)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the study population is selected from Ghent university hospital

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent university hospital

Ghent, Gent, 9000, Belgium

Location

MeSH Terms

Conditions

Dental Caries; Disease; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits

Central Study Contacts

sachiko maemoto

CONTACT

+3293324057; Sachiko.Maemoto@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)