NCT07555223

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Apr 2025Jul 2027

Study Start

First participant enrolled

April 3, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of Intraoral Scan for Dental Plaque Detection

    Diagnostic accuracy of intraoral scan compared with plaque assessment using disclosing agents.

    At baseline and 2 weeks

Secondary Outcomes (1)

  • Agreement Between Intraoral Scan and Reference Standard for Dental Caries Detection

    At baseline and 2 weeks

Study Arms (1)

Study Participants

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

Diagnostic Test: intraoral scan

Interventions

intraoral scanDIAGNOSTIC_TEST

intraoral scanning used for assessment of dental plaque and caries.

Study Participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adults aged 18 to 70 years
  • Not pregnant and not planning pregnant
  • At least 20 teeth present
  • Ability to provide informed consent

You may not qualify if:

  • Conditions that prevent proper intraoral examination (e.g., severe gag reflex, limited mouth opening)
  • patient unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandarts Praktijk VERVACK

Wondelgem, Botestraat, 104, Belgium

RECRUITING

MeSH Terms

Conditions

Dental PlaqueDental Caries

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesTooth Demineralization

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start

April 3, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations