NCT04043039

Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

Platelet Rich Fibrin in the Treatment of Palatal Wounds After Full Thickness Palatal Grafts Harvesting: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a flap with connective tissue graft(CTG). In the test group (20 patients) and in the control group 2 a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups 2-4 patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

Detailed description

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Palatal wound bandage with PRF	palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes
PROCEDURE	Palatal wound bandage with Gelatine Sponge	palatal wound will be protected by gelatine sponge

Timeline

• Start date: 2019-09-02
• Primary completion: 2019-10-02
• Completion: 2019-11-04
• First posted: 2019-08-02
• Last updated: 2023-03-15

Locations

1 site across 1 country: Italy