Platelet Rich Fibrin in the Treatment of Palatal Wounds

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02438046
• Other study ID #: 1/2015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 27, 2015
• Last updated: May 5, 2015
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: G. d'Annunzio University
• Contact: Michele Paolantonio, MD; DDS
• Phone: +393395204073
• Email: mpaoantonio[@]unich.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Palatal wound bandage
Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.

Locations

Country	Name	City	State
Italy	G. d'Annunzio University	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound		four weeks	Yes