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

NCT ID: NCT04812405

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Teeth

Occlusal examination

Group Type OTHER

Trios4

Intervention Type DIAGNOSTIC_TEST

Examination of occlusal surfaces with 3D scanner and optical criteria

Interventions

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Trios4

Examination of occlusal surfaces with 3D scanner and optical criteria

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ICDAS

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Rahiotis Chris

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dentistry

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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385

Identifier Type: -

Identifier Source: org_study_id

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