Platelet Rich Fibrin in the Treatment of Palatal Wounds

Study Overview
=================
Brief Summary
-----------------
In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the epithelialized connective tissue graft palatal donor site healing acceleration and in the patient's morbidity reduction. Forty 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 group 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.

Official Title
-----------------
Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial

Conditions
-----------------
Gingival Recession

Intervention / Treatment
-----------------
* Procedure: Palatal wound bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are as follows: to have a single gingival recession to be treated by a mucogingival surgery intervention to be in good systemic health to have a good oral hygiene Exclusion Criteria: no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation; no smoking habits; no periodontal surgery on the experimental sites; no inadequate endodontic treatment no tooth mobility at the site of surgery

Ages Eligible for Study
-----------------
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palatal wound bandage by PRF<br>Intervention: In the test group (n=20 patients) the 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<br>* Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.<br>|
| Placebo Comparator: Palatal wound bandage by gelatin sponge<br>Intervention: The control group patients (n=20) will have their palatal wound medicated by absorbable gelatin sponge. | Procedure: Palatal wound bandage<br>* Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound |  | four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Connective Tissue Grafts, Wound healing, Biomaterials, Pain, Clinical Trials, Mucogingival Surgery