harvest of free gingival grafts with or without the application of hemostatic sutures

Conditions: Thin-gingiva; Mucogingival Deformity on Edentulous Ridge; Gingival Recession

Summary: randomized, single-center trial with 2 parallel arms and a 1:1 allocation ratio, with the aim of comparing clinical and microvascular 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).

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.

Eligibility criteria:
inclusion criteria: * any adult (≥ 18 year old), male or female patient from the university complutense of madrid, being able to sign an informed consent form, presenting any mucogingival condition requiring the placement of a free gingival graft or a connective tissue graft obtained through the extra oral de-epithelialization of a free gingival graft. exclusion criteria: * patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found at any time through the study: systemic primary exclusion criteria: 1. compromised general health status contraindicating the study procedures (≥asa iv); 2. drug abuse, alcohol abuse, or smoking \> 10 cigarettes a day; 3. chronic use of corticosteroids, nsaids, or immune-modulators (any type, any dose); 4. use of anti-aggregant or anti-coagulant drugs; 5. pregnant or nursing women; 6. hypersensitivity to ibuprofen. local primary exclusion criteria: 1. history of previous soft tissue surgeries in the area of the harvest; 2. preoperative evidence of a palate thickness \< 2mm in the area of interest; 3. intraoperative evidence of active bleeding from the harvesting site at the end of surgery, which impedes the stabilisation of a good coagulum over the harvesting area; secondary exclusion criteria: a. non compliant patients: poor oral hygiene (fmps \>20%) at 2 consecutive visits.

Keywords: connective tissue graft free gingival graft mucogingival surgery mucogingival conditions gingival recession