CClinicalTrials.gg
CompletedNCT04812405Updated Mar 23, 2021

Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.

An interventional study of Trios4 in Healthy Patients, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Per ClinicalTrials.gov, last updated 2021-03-23.

Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Sex
All
01

Study summary

This in vivo study with in vitro validation assessed four different algorithms (ALG1-ALG4) implemented in the intraoral scanner system for automated caries detection and classification. 3D scans of the examined teeth were obtained both in vivo and vitro, i.e. before and after tooth extraction, in order to assess any possible differences in the performance of the algorithms at different conditions. The latter could potentially help drawing some conclusions regarding i) the validity of the in vitro studies assessing fluorescence method for caries detection, and ii) the in vivo applicability of in vitro results obtained in the past and the future. Additionally, visual-tactile examination using the ICDAS (ICDAS II) criteria19 was conducted on the same teeth in vivo and histological assessment was used as reference test in vitro.

02

Conditions studied

  • Healthy Patients

Keywords

  • caries detection
  • in vivo
  • intraoral scanner
  • ICDAS
  • histology
03

In context

Lead sponsor

National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with permanent molars / premolars,
  • Sound teeth or with caries lesions on the occlusal surfaces.

Exclusion criteria

Exclusion Criteria:

  • Front teeth / deciduous teeth
  • Teeth with fillings
  • Teeth with broken crown
  • Teeth with extensive lesions on the lateral surfaces.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Other
    Teeth

    Occlusal examination

    Diagnostic Test: Trios4

Interventions

  • Diagnostic testTrios4

    Examination of occlusal surfaces with 3D scanner and optical criteria

    Also known as: ICDAS

06

What researchers measure

Primary outcomes

  1. Agreement of In vivo validation with in vitro caries detection

    To assess the difference in vivo and in vitro the fluorescence emitted of the TRIOS FLUO intraoral scanner from occlusal surface from 3rd molar before and after extraction

    Time frame: 1 year

07

Study locations

1 site
  • Dentistry
    Athens, 11527, Greece
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04812405
Lead sponsor
National and Kapodistrian University of Athens
Responsible party
Rahiotis Chris (Associate Professor, National and Kapodistrian University of Athens) — Principal investigator
First posted
Mar 23, 2021
Start date
Jun 3, 2020
Primary completion
Nov 15, 2020
Completion
Mar 10, 2021
Last update
Mar 23, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion