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

• Grant number: 20/16690-0
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: June 01, 2022
• End date: May 31, 2025
• Field of knowledge: Health Sciences - Dentistry - Pediatric Dentistry
• Principal Investigator: Thais Marchini de Oliveira Valarelli
• Grantee: Eloá Cristina Passucci Ambrosio
• Host Institution: Hospital de Reabilitação de Anomalias Craniofaciais (HRAC). Universidade de São Paulo (USP). Bauru , SP, Brazil

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)

Scientific publications

(6)

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

AMBROSIO, ELOA CRISTINA PASSUCCI; FURIATTO, ARTHUR P.; COUTINHO, MARCELLI S.; QUAGLIATO, DEBORA R.; CARRARA, CLEIDE FELICIO CARVALHO; MACHADO, MARIA APARECIDA ANDRADE MOREIRA; OLIVEIRA, THAIS M.; JORGE, PAULA K.. What Are the Effects on Palate of Early Lip Surgery in Children With Cleft Lip and Palate? Cross-Sectional Evaluation From 5-Year-Old. JOURNAL OF CRANIOFACIAL SURGERY, v. 34, n. 6, p. 4-pg., 2023-09-01. (21/12424-6, 20/16727-0, 20/16690-0)

RANDO, GABRIELA MENDONCA; AMBROSIO, ELOA CRISTINA PASSUCCI; JORGE, PAULA KARINE; SFORZA, CHIARELLA; MENEZES, MARCIO; DE ALMEIDA, ANA LUCIA POMPEIA FRAGA; SOARES, SIMONE; DALBEN, GISELE SILVA; TONELLO, CRISTIANO; CARRARA, CLEIDE FELICIO CARVALHO; et al. Three-Dimensional Anthropometric Analysis of the Effect of Lip Reconstructive Surgery on Children with Cleft Lip and Palate at Three Different Times. CHILDREN-BASEL, v. 11, n. 7, p. 10-pg., 2024-07-01. (20/07072-0, 21/12424-6, 20/16690-0)

AMBROSIO, ELOA CRISTINA PASSUCCI; SFORZA, CHIARELLA; CERON-ZAPATA, ANA MARIA; LOPEZ-PALACIO, ANA MARIA; DE MENEZES, MARCIO; CARRARA, CLEIDE FELICIO CARVALHO; MACHADO, MARIA APARECIDA ANDRADE MOREIRA; OLIVEIRA, THAIS MARCHINI. Comparison of Three Unilateral Cleft Lip and Palate Treatment Protocols in Infancy. PEDIATRIC DENTISTRY, v. 45, n. 4, p. 7-pg., 2023-07-01. (17/02706-9, 20/16690-0, 21/12424-6)

JORGE, PAULA KARINE; AMBROSIO, ELOA CRISTINA PASSUCCI; PUCCIARELLI, MARIA GIULIA REZENDE; SOARES, SIMONE; CARRARA, CLEIDE FELICIO DE CARVALHO; SFORZA, CHIARELLA; MACHADO, MARIA APARECIDA ANDRADE MOREIRA; OLIVEIRA, THAIS MARCHINI. Analysis of Dental Arch Symmetry of Children With Unilateral Cleft Lip and Palate: Seven-Year Follow-Up. International Journal of Paediatric Dentistry, v. N/A, p. 9-pg., 2024-12-08. (21/12424-6, 20/16690-0)

AMBROSIO, E. C. P.; BERGAMO, M. T. O. P.; SFORZA, C.; CARRARA, C. F. C.; MACHADO, M. A. A. M.; OLIVEIRA, T. M.. Across-surface distances after one- and two-stage palatoplasty in children with oral cleft. Brazilian Journal of Medical and Biological Research, v. 57, p. 7-pg., 2024-01-01. (21/12424-6, 20/16690-0)

BERGAMO, MARIEL TAVARES OLIVEIRA PRADO; AMBROSIO, ELOA CRISTINA PASSUCCI; CARRARA, CLEIDE FELICIO DE CARVALHO; MACHADO, MARIA APARECIDA ANDRADE MOREIRA; OLIVEIRA, THAIS MARCHINI. Palatal symmetry analysis of surgical protocols for oral clefts by 3D stereophotogrammetry. ODONTOLOGY, v. N/A, p. 8-pg., 2025-01-03. (21/12424-6, 20/16690-0)