2.1. Trial Design and Participants
dentine lesions, Caries, caries
DENTAL CARIES, SYSTEMIC DISEASE, CARIES, CARIES, MOTOR DISORDERS
This study was designed as a double-blind three-parallel-group randomized controlled trial, in which the subject, operator, and evaluator were masked to the group assignment. It was accepted by the Comisión de Ética, Facultad de Odontología, Universidad de Buenos Aires No. FOUBA 29/05/2013-52.A sample size calculation was performed using G*Power10 (3.1 An effect size 0.10 for the new treatment was set with an α err prob = 0.05 and a Power (1-β err prob) = 0.95. The non-centrality parameter λ resulted in 14.18 with a critical χThe study was carried out between 2019 and 2022 at two schools presenting homogeneous characteristics in terms of social risk.The children (All parents/caregivers of the children received a leaflet requesting their approval to enrol their children; for those whose families decided not to be included into the trial, the children received the dental treatment needed, but their data were not evaluated. The positive reply rate was 96.7% (The inclusion criteria were children between 4 and 11 years old attending the selected schools. Exclusion criteria: children with systemic diseases or systemic disease treatments, motor disorders, and children receiving preventive measures in other public, private, or social-security dental services; one-hundred-eighty subjects were enrolled and three groups were randomly created via a systematic cluster sampling procedure using ExcelEach child underwent a clinical examination to determine dental status according to the ICDAS II criteria 14, performed under standardized conditions, using light, dental mirror, WHO probe, and magnification (2.5×). The dental exams were performed by 3 calibrated researchers (S.A., F.S., L.R.). The calibration was carried out prior to the start of the trial with the reference examiner (A.S.).The calibration strategy consisted of:Expository class (2 h) with photographs (Caries detection using extracted teeth (Clinical practice (20 h), which included the following phases:Assignment to each operator of 6 volunteer subjects who provided a balanced number of dental surfaces with ICDAS14 codes from 1 to 6.Observation and recording of the findings in an ad hoc spreadsheet, in the charge of each independent operator. The visual–tactile clinical examination was performed with frontal light, WHO probes, magnification (3.5×), and drying of surfaces with air.Re-evaluation (one-week after) of each patient by the reference examiner and recording of the findings.Inter- and intra-examiner reliability was evaluated by comparing the benchmark and the examiners’ outcomes and the percentage of agreement using Cohen’s kappa statistic for sound surfaces, enamel and dentine lesions, and caries activity.On the basis of the clinical examination, beside the ICDAS14,15 score, the CTNI (11) was also computed. The CTNI13 is based on the interaction of two axes: one based on the progression of the lesion and the other on the technological resources needed to control the risk of dental caries. The progression axis identifies the magnitude of severity and extent. The magnitude of severity component identifies the process of tissue involvement of the dental caries lesion, moving from the white spot lesion to the subsequent progression of the lesion towards cavitation. The magnitude of extension in the “oral unit” is expressed by the number of oral quadrants with visible lesions. The technological axis includes the risk component and the available technological development component. The risk component is the result of the identified variables while the technological development is based on contextualized scientific evidence and is expressed as the appropriate strategies and their application per oral unit and teeth, according to the extent recorded in the dental quadrants.No instrumentation is required for its determination. It is a visual index whose only requirement is good lighting and a clean mouth.