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

Assessment of the Difference of Fluoresce of the TRIOS 4 Intraoral Scanner of the Same Surface at In Vivo and In Vitro Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy Patients
• Intervention / Treatment: Diagnostic test: Trios4

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Teeth; Occlusal examination	Diagnostic test: Trios4; Examination of occlusal surfaces with 3D scanner and optical criteria; Other Names: ICDAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: histology; ICDAS; caries detection; in vivo; intraoral scanner
• Other Study ID Numbers: 385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No