Sustained insulin-delivery as a growth factor for modulating oral mucosa healing: A case series.

OBJECTIVE

(s): In clinical practice, achieving a smooth recovery is essential, with an emphasis on optimizing therapeutic outcomes and ensuring patient comfort. The use of targeted therapies to modulate the host response toward resolution is highly desirable. Thus, this study aims to evaluate a novel sustained insulin-delivery system (DS) as a growth factor for oral wounds, integrating device characterization, in vitro and clinical assessments, and focusing on the modulation of the oral mucosa healing.

DESIGN

The device was evaluated for thickness, water vapor permeability, scanning electron microscopy, tensile strength, swelling degree, and insulin in vitro release in human saliva. Cytotoxicity and genotoxicity were assessed using Human Epidermal Keratinocyte (HaCat), Foreskin Fibroblast (HFF-1), and Gingival Fibroblast (HGF) cells. The 3-month outcomes of palatal wound healing following free gingival graft harvesting in twelve patients, using the DS, were evaluated through clinical and immunological parameters.

RESULTS

The DS exhibited great permeability, elasticity, and a rough surface. It demonstrated an exponential insulin release during the first 12 h, delivering 30% of its content. Afterwards, a controlled diffusional mechanism was achieved, leading to sustained delivery over 3 days. No cyto/genotoxicity was observed in cell types. No adverse effects were observed during the clinical use of the biomaterial. Clinical outcomes showed accelerated palatal wound closure along with increased epithelialization on days 7 and 14 posttherapy (p < 0.001). The DS application did not elicit a pro-inflammatory response.

CONCLUSIONS

DS displayed suitable physical properties for oral application, low cytotoxicity/genotoxicity, and favorable clinical outcomes. Its efficacy warrants validation in future clinical trials.