NCT05381623

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

Microvascular Response to the Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures: a Randomized Controlled Clinical Trial Assessing Palatal Blood Flow by Laser Speckle Contrast Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Thin-gingiva
• Mucogingival Deformity on Edentulous Ridge
• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Simplified suture-less approach	Immediately after the harvest of a free gingival graft from hard palate, at least a half carpule of local anesthetic (articaine 4% 1:100.000 epinephrine) will be infiltrated within the apical border of the harvesting site and another half mesially and distally to the harvesting site. At the end of the mucogingival procedure, the donor site will be evaluated to inquire regarding the presence of a competent coagulum over the wound area. In such a case, no additional procedure will be performed at the recipient site.
PROCEDURE	Application of hemostatic sponges and compressive sutures	Immediately after the harvest of a free gingival graft from hard palate, hemostatic collagen sponges will be applied over the harvesting site and a series of tooth suspended external mattress sutures (PGA 5/0) will be applied over the area, in order to provide a compressive effect.

Timeline

• Start date: 2022-05-20
• Primary completion: 2022-06-14
• Completion: 2022-09-30
• First posted: 2022-05-19
• Last updated: 2023-10-04

Locations

1 site across 1 country: Spain