Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate

Wound Healing Clinical Trial

Official title: Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate: Randomized Clinical Study

Status Recruiting

Clinical Trial Summary

The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate.

Clinical Trial Description

Surgical procedures for the reconstruction of gingival and peri-Implant tissues with the purpose of restoring function and aesthetics are commonly used in the dental practice. The use of free gingival graft (FGG), despite being considered the gold standard, causes great morbidity and postoperative pain. Thus, in order to reduce these complications, some biomaterials have been explored to accelerate healing and bring greater comfort to the patient. The present study aims to: 1. manufacture silk fibroin membranes (SF), loaded or not with neurotensin (NT); 2. evaluate, clinically and immunologically, the effect of the membranes on open wounds at palate sites. After the manufacture of the membranes they will be characterized by visual aspect, thickness, mechanical properties, surface texture, water vapor permeability, enzymatic degradation and swelling. Posteriorly, sixty six (n = 66) patients requiring exodontia and ridge preservation for future implant placement will be randomly assigned into three groups: Control - Free Gingival Graft (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance; Group SF - Fibroin membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of the fibroin membrane at the palatal wound site; Group SF + NT - Free Gingival Graft + Neurotensin-loaded Fibroin Membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of neurotensin-loaded fibroin membrane at the palatal wound site. The repair of the palatine donor area will be evaluated by clinical parameters such as remaining wound area, tissue thickness, re-epithelialization and early-wound healing index at baseline, 7, 14, 21, 30, 45, and 90 days after the procedure; and patient-centered outcomes by post-operative discomfort, tissue edema and number of analgesic pills used for 14 days after the procedure. In addition, inflammatory cytokines and growth factors will be assessed using the palatal wound inflammatory exudate 3 and 7 days after surgery. For the descriptive statistics, the mean ± standard deviation will be used; Normality: Shapiro-Wilk test; Clinical trials: ANOVA for intra and inter group calculations + Tukey test for multiple comparisons when the Shapiro-Wilk p value ≥ 0.05. If p Shapiro-Wilk <0.05, will be analyzed using the Friedman test (intragroup) and Mann-Whitney tests (intergroup); Parameters centered on patients: T test. ;

Related Conditions & MeSH terms

• Palate; Wound
• Wound Healing
• Wounds and Injuries

• NCT number: NCT05191082
• Study type: Interventional
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Mauro P Santamaria
• Phone: 1239479062
• Email: mauro.santamaria@unesp.br
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Completion date: July 1, 2022