Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures

This randomized two parallel arms controlled clinical trial aims to establish the early microvascular healing, clinical healing, and patients related outcomes, which follow the harvest of a free gingival graft, where hemostasis has been achieved with either compressive sutures and homeostatic sponges (control) or with a simplified suture-less approach (test). The primary outcome is the microvascular healing of the palate14 days after surgery, assessed by measuring the palatal blood flow with a Laser Speckle Contrast Imaging (LSI), expressed in Laser Speckle Perfusion Units (LSPU). Secondary outcomes include the palatal blood flow at 3, 7 and 30 days after surgery, the clinical healing of the palate, the occurrence of postoperative bleeding and patients related outcome measures assessed 14 postoperative days. A figure of 16 subjects per group was obtained based on an expected difference of 7 LSPU, considering a SD of 6.3 SLPU, 80% power, alpha 0.05, and assuming a foreseen drop-out rate of 15%. Patients will be randomly allocated to two groups: test (simplified suture-less approach) and control (compressive sutures and homeostatic sponges). Cases will be the unit of analysis and T-student (normal distribution) or U Mann Whitney (non normal distribution or non parametric variables) will be performed setting the significance level at p \< 0.05.