Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Palatal wound bandage with PRF
* Procedure: Palatal wound bandage with Gelatine Sponge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FULL THICKNESS PALATAL GRAFT<br>the full thickness palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membrane or by gelatine sponge | Procedure: Palatal wound bandage with PRF<br>* palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes<br>Procedure: Palatal wound bandage with Gelatine Sponge<br>* palatal wound will be protected by gelatine sponge<br>|
| Active Comparator: FREE GINGIVAL GRAFT<br>the Epithelialized Free Gingival Grafts palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membrane or by gelatine sponge | Procedure: Palatal wound bandage with PRF<br>* palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes<br>Procedure: Palatal wound bandage with Gelatine Sponge<br>* palatal wound will be protected by gelatine sponge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to obtain a complete re epithelialization of the palatal wound | The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound | 4 weeks |