Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions
NCT ID: NCT04900246
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2022-01-20
2022-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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).
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.
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.
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.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Surfaces with evident proximal cavities (marginal crest break);
* Absence of adjacent tooth (absence of proximal contact).
4 Years
10 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nove de Julho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sandra Kalil Bussadori
Principal Investigator
References
Explore related publications, articles, or registry entries linked to this study.
Sobral APT, Goncalves MLL, D Annibale AS, Santos EM, Guedes CC, Gallo JMAS, Ferri EP, Moretti LAC, Motta LJ, Deana AM, Horliana ACRT, Kalil Bussadori S. Evaluation of different methods for the diagnosis of primary caries lesions: Study protocol for a randomized controlled clinical trial. PLoS One. 2022 Aug 24;17(8):e0273104. doi: 10.1371/journal.pone.0273104. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
iTero
Identifier Type: -
Identifier Source: org_study_id