Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions

November 18, 2021 updated by: Sandra Kalil Bussadori, University of Nove de Julho

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visual Inspection + BWX Radiographic Assessment + Assessment of the iTero Element 5D scan
In this group, the evaluations will follow this order. First the visual inspection, then the bitewing X-ray assessment and, lastly, the iTero assessment.
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.
Experimental: Visual Inspection + Assessment of the iTero Element 5D scan + BWX Radiographic Evaluation
In this group, the evaluations will follow this order. First the visual inspection, then the iTero assessment and, lastly, the bitewing X-ray assessment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of primary caries lesions through visual inspection (ICDAS)
Time Frame: Baseline.
For the visual inspection of caries, 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.
Baseline.
Diagnosis of primary caries lesions through the iTero Element 5D scan
Time Frame: Baseline.
For the diagnosis through 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.
Baseline.
Diagnosis of primary caries lesions BWX Radiographic Assessment
Time Frame: Baseline.
For this diagnosis, 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).
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2022

Primary Completion (Anticipated)

June 20, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • iTero

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caries Class II

Clinical Trials on Visual Inspection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe