NCT04900246

Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions

Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions: Study Protocol for a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Caries Class II

Interventions

Type	Name	Description
PROCEDURE	Visual Inspection	The examiners will evaluate the surfaces included in the study independently and without knowledge of the results of the other examiner, after prophylaxis, using a mouth mirror and a WHO probe or "Ball point". The evaluations will be carried out in a dental chair with the aid of a reflector. The teeth will be examined moist, and afterwards, they will be dried for 5 seconds with the use of a triple syringe. For visual inspection, the International Caries Detection and Assessment System (ICDAS) evaluation system will be used. Complete ICDAS has seven categories, the first for healthy teeth (code 0) and the next two for limited enamel caries, white/brown stain (codes 1 and 2). The following two categories (codes 3 and 4) are considered to be caries that extend to the enamel without exposed dentin. And the two remaining categories (codes 5 and 6), are considered caries with exposed dentin.
RADIATION	BWX Radiographic Assessment	Participants will be radiographed with a digital X-ray device (DIOX-602, Micro Imagem, Indaiatuba, Brazil) with a regulation of 60 kV and 2 mA and exposure time of 0.10s. The technique used will be the interproximal/bitewing (BWX), with the FIT T1 Digital Sensor (external dimensions: 36.7mm x 24.3mm/sensitive area dimensions: 30.0mm x 20.0mm - 600mm²) and the sockets will be standardized with use of Han-Shin radiographic positioners (Jon, São Paulo, Brazil).
DEVICE	Assessment of the iTero Element 5D scan	For scanning, the iTero 5D (Align Technology) equipment featuring NIRI Technology will be used. The Infrared Imaging Technology (NIRI) is a diagnostic tool that allows the detection of interproximal and occlusal caries in several stages, from the initial enamel caries to lesions in the amelo-dentin junction, without the use of ionizing radiation. Infrared is the region of the electromagnetic spectrum between 0.7 and 2.0 micrometers (µm). The iTero Element 5D imaging system uses wavelength light (= 850 nm) in an electromagnetic spectrum that, in interaction with the hard tooth tissue, provides additional data on its structure.

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-06-20
• Completion: 2022-08-30
• First posted: 2021-05-25
• Last updated: 2021-12-01