Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

• Sponsor: G. d'Annunzio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04043039
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 38.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Procedure: Palatal wound bandage with PRF; Procedure: Palatal wound bandage with Gelatine Sponge	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Platelet Rich Fibrin in the Treatment of Palatal Wounds After Full Thickness Palatal Grafts Harvesting: A Randomized Clinical Trial
• Actual Study Start Date: Sep 2, 2019
• Actual Primary Completion Date: Oct 2, 2019
• Actual Study Completion Date: Nov 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FULL THICKNESS PALATAL GRAFT 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; 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
Active Comparator: FREE GINGIVAL GRAFT 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; 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

Outcome Measures

Primary Outcome Measures

1. Time needed to obtain a complete re epithelialization of the palatal wound [4 weeks]

   The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G. d'Annunzio University	Chieti	CH	Italy	66100

Sponsors and Collaborators

• G. d'Annunzio University

Investigators

• Study Director: michele paolantonio, università G. D'annunzio Chieti-Pescara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele Paolantonio, Head of Periodontology, G. d'Annunzio University
• ClinicalTrials.gov Identifier: NCT04043039
• Other Study ID Numbers: 072019
• First Posted: Aug 2, 2019
• Last Update Posted: Dec 3, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gingival Recession

Study Results

No Results Posted as of Dec 3, 2019