Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions

University of Nove de Julho

Status and phase: Unknown; Phase 1

Conditions: Caries Class II

Treatments: Radiation: BWX Radiographic Assessment; Device: Assessment of the iTero Element 5D scan; Procedure: Visual Inspection

Study type: Interventional

Funder types: Other

Identifiers

NCT04900246

iTero

Details and patient eligibility

About

According to the World Health Organization (WHO), dental caries is considered one of the major pediatric health problems worldwide, due to its high prevalence and incidence. Therefore, the early diagnosis of caries lesions is a fundamental procedure for building the treatment plan, aiming at prevention, minimal intervention and the promotion of oral health. The present study aims to evaluate, through a randomized and controlled clinical study, which is the best strategy for diagnosing primary caries lesions located in the interproximal region in individuals aged from 4 to 10 years. Diagnostic methods will be analyzed and compared: visual clinical examination using the International Caries Detection and Assessment System (ICDAS), iTero Element 5D System (intraoral scanner with NIRI technology) and bitewing radiography (BWX). All evaluations will be carried out by 02 examiners. The examiners will be trained and calibrated to use the visual and radiographic criteria, and also to use the iTero 5D intraoral scanner, following the manufacturer's guidance.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients of both sexes who seek dental treatment at the Dentistry Clinic of Universidade Metropolitana de Santos.
• Be between 04 and 10 years old;
• Good general health;
• Present at least two tooth surfaces that can be included in the study.

Exclusion criteria

• Dental surfaces with proximal restorations;
• Surfaces with evident proximal cavities (marginal crest break);
• Absence of adjacent tooth (absence of proximal contact).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Visual Inspection + BWX Radiographic Assessment + Assessment of the iTero Element 5D scan

Experimental group

Description:

In this group, the evaluations will follow this order. First the visual inspection, then the bitewing X-ray assessment and, lastly, the iTero assessment.

Treatment:

Radiation: BWX Radiographic Assessment

Device: Assessment of the iTero Element 5D scan

Procedure: Visual Inspection

Visual Inspection + Assessment of the iTero Element 5D scan + BWX Radiographic Evaluation

Experimental group

Description:

In this group, the evaluations will follow this order. First the visual inspection, then the iTero assessment and, lastly, the bitewing X-ray assessment.

Treatment:

Radiation: BWX Radiographic Assessment

Device: Assessment of the iTero Element 5D scan

Procedure: Visual Inspection