Randomized clinical trial: evaluation of the effectiveness of an application for mobile phones as an aid in the prevention of early childhood caries

Abstract

Considering the impacts caused by early childhood caries (ECC) on the quality of life of children and their families, as well as the great diffusion and influence of digital media on people's health, this study aims (1) to investigate the topics and contents related to the most frequently questions asked about ECC, and (2) to evaluate the effectiveness of text messages sent via cellphones to the parents or caretakers as an adjuvant method for the prevention of ECC. The evidence of the first phase will be produced by conducting focus groups composed of parents or caretakers of children aged between 36 and 60 months with high risk of dental caries, who will be recruited at the Clinics of Pediatric Dentistry, Bauru School of Dentistry. A moderator and an assistant will conduct the groups in triplicate. The meetings will be filmed, photographed and recorded on audio files for further qualitative analysis of content. After reading the transcripts of the audio, two independent investigators will attribute specific codes for the textual passages according to their themes. A list of codes will be developed on the basis of the issues identified. All the qualitative analysis will be performed using the NVivo® software version 10. In the second phase, a single-blind, randomized, parallel-group clinical trial will be conducted. Dyads of parents/caretakers and children aged between 36 and 60 months with high risk of dental caries, recruited in kindergartens and schools of the city of Bauru-SP, will be randomly assigned to two distinct groups, test and control, according to health literacy levels, age and gender. Participants from test group will receive weekly text messages via WhatsAppTM with preventive and education-related contents that emerged during the first stage of this study, while participants from control group will not receive messages. Parent/child dyads will return to dental visits every three months for a year. In each session, the primary outcomes will be evaluated by a dentist, being related to sugar consumption and ICDAS index scores, visible plaque index and community periodontal index of the child. The children will also receive dental prophylaxis and fluoride varnish application, if necessary, while parents receive instructions for oral hygiene and diet. Prior to the statistical analysis, the data will be examined for missing values, outliers, normality and homogeneity. To investigate the quality of randomization, potential differences between the characteristics of participants of the test and control groups will be determined systematically by Student's t tests for continuous variables and Chi-square for categorical variables. In cases of loss of participants during the study, Listwise Deletion method will be applied if the missing values satisfy the criteria of missing completely at random (MCAR). Otherwise, multiple imputation data strategies will be applied to. The Kolmogorov-Smirnov test and Levene will be used to test the normality and homogeneity of the data, which will determine further statistical analyses for the determination of significant differences between the two groups (P<0.05). (AU)