Innovation in the rehabilitation protocol with digital workflow in children with cleft lip and palate

Abstract

The purpose of this study is to perform an anthropometric longitudinal analysis to quantify the dimensional changes of the face and palate in children with unilateral cleft lip and palate submitted to an innovative rehabilitation protocol. The selected sample will be divided into Group 1 (G1) - participants submitted to the conventional treatment of HRAC/USP (cheiloplasty at 3 months and palatoplasty at 12 months of life); Group 2 (G2) - participants submitted to the new rehabilitation protocol with the use of pre-surgical orthopedic aligners with nasal-alveolar molding from 15 days of life to 6 months of life. Cheiloplasty will be performed at 6 months and palatoplasty at 12 months of age. In addition to clinical care in both groups, G2 will be monitored remotely through telehealth. Participants will be assessed in phase 1 - pre-orthopedics; phase 2 - pre-cheiloplasty and phase 3 - post-cheiloplasty. Linear measurements, area, volume of the nasolabial region and dental arches will be quantified; palatal superimposition will also be performed. The plastic surgeons will analyze the criteria: nasal symmetry, presence of scar, scar severity, esthetics and satisfaction through the Likert Scale. The legal guardians of the participants will answer the Impact Event Scale questionnaire to assess the subjective stress related to the rehabilitation protocol. The reliability analysis of the methodology will be evaluated by means of linear regression analysis and Bland-Altman agreement, and by the Dahlberg formula. The Shapiro-Wilk test will be used to determine parametric and / or non-parametric tests in quantitative data. Paired T-Test, analysis of variance with post-hoc Tukey, Pearson's correlation coefficient will be applied for the analysis of changes within each sample group. Independent t test will be used to verify intergroup results. Multivariate analysis of linear mixed effects regression will be applied to assess the longitudinal development of the palate and face, in addition to estimating the growth of participants by group and sex. Logistic regression will be used for sample homogenization. The data obtained from the questionnaires will be analyzed with non-parametric tests. If necessary, other tests will be applied (p <0.05). (AU)