Platelet Rich Fibrin in the Treatment of Palatal Wounds

Phase 4

• Conditions: Gingival Recession
• Interventions: Procedure: Palatal wound bandage

• Registration Number: NCT02438046
• Lead Sponsor: G. d'Annunzio University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-27
• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-08
• Last Update Posted: 2015-05-08
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palatal wound bandage by gelatin sponge	Palatal wound bandage	Intervention: The control group patients (n=20) will have their palatal wound medicated by absorbable gelatin sponge.
Palatal wound bandage by PRF	Palatal wound bandage	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

Primary Outcome Measures

Name	Time	Method
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound	four weeks

Trial Locations

Locations (1)

G. d'Annunzio University; 🇮🇹 Chieti, CH, Italy