Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Palatal wound bandage with PRF; Procedure: Palatal wound bandage with Gelatine Sponge

• Registration Number: NCT04043039
• 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 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

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 Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Study Start: 2019-09-02
• Primary Completion: 2019-10-02
• Study Completion: 2019-11-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FULL THICKNESS PALATAL GRAFT	Palatal wound bandage with PRF	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
FULL THICKNESS PALATAL GRAFT	Palatal wound bandage with Gelatine Sponge	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
FREE GINGIVAL GRAFT	Palatal wound bandage with PRF	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
FREE GINGIVAL GRAFT	Palatal wound bandage with Gelatine Sponge	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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