A New Drug Delivery System - Silk fibroin film loaded or not with insulin on palatal mucosa wound healing: in vitro study and a randomized clinical trial.

• Grant number: 21/05963-8
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: April 01, 2022
• End date: November 30, 2023
• Field of knowledge: Health Sciences - Dentistry - Periodontology
• Principal Investigator: Mauro Pedrine Santamaria
• Grantee: Manuela Maria Viana Miguel
• Host Institution: Instituto de Ciência e Tecnologia (ICT). Universidade Estadual Paulista (UNESP). Campus de São José dos Campos. São José dos Campos , SP, Brazil

Abstract

There are several types of periodontal and peri-implant soft tissue defects that require surgical treatment to reestablishment function and aesthetics. Therefore, surgical procedures for the reconstruction of the gingival and peri implant tissues are routinely performed. However, these procedures do not always have predictable outcomes and problems with the wound healing process can occur, which can impair the final outcomes and generate professional and patient frustrations. To overcome this problem, new materials, drugs, and devices have been used to improve the results of surgical procedures. For this, biomaterial development, characteristic analysis and in vitro assess will be performed to evaluate the delivery system. In sequence, evaluate clinically and through the concentration of inflammatory markers, growth factor and microbiome 3 months follow-up of accelerating wound repair after harvesting graft using this delivery system. For this, a controlled clinical trial will be carried out following the CONSORT STATEMENT 2010. Seventy-five patients with indication of anterior maxillary tooth extraction for ridge preservation will be enrolled into 3 groups: Control Group (C) (n=25): open wound on palatal mucosa that will not receive any treatment. Blank Film Group (BF) (n=25): open wound on palatal mucosa that will receive silk fibroin film as dressing. Insulin-loaded film (IF) (n=25): open wound on palatal mucosa that will receive an insulin-loaded silk fibroin film as a delivery system. Values for clinical, immunological, histological, and microbiome assay will be examined by repeated ANOVA measures to assess differences within and between groups, followed by a Tukey test for multiple comparisons when the value of p Shapiro-Wilk e 0.05. Those with Shapiro-Wilk p values <0.05 will be analyzed using the Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Values referring to patient-centered parameters will be analyzed using the T-Test.