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Clinical Trials/NCT07555223
NCT07555223
Recruiting
Not Applicable

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

University Ghent1 site in 1 country50 target enrollmentStarted: April 3, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Diagnostic Accuracy of Intraoral Scan for Dental Plaque Detection

Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Study Participants

All participants undergo intraoral scanning, visual inspection, plaque disclosure, and bitewing radiography for the assessment of dental plaque and caries.

Intervention: intraoral scan (Diagnostic Test)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Agreement Between Intraoral Scan and Reference Standard for Dental Caries Detection(At baseline and 2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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