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

Healthy Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812405
• Other study ID #: 385
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: March 2021
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 10, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Patients

Intervention

Diagnostic Test:
• Trios4
Examination of occlusal surfaces with 3D scanner and optical criteria

Locations

Country	Name	City	State
Greece	Dentistry	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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