Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

NCT ID: NCT04043039

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2019-11-04

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Palatal wound bandage with PRF

Intervention Type: PROCEDURE

palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes

Palatal wound bandage with Gelatine Sponge

Intervention Type: PROCEDURE

palatal wound will be protected by gelatine sponge

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

Group Type: ACTIVE_COMPARATOR

Palatal wound bandage with PRF

Intervention Type: PROCEDURE

palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes

Palatal wound bandage with Gelatine Sponge

Intervention Type: PROCEDURE

palatal wound will be protected by gelatine sponge

Interventions

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

Intervention Type: PROCEDURE

Palatal wound bandage with Gelatine Sponge

palatal wound will be protected by gelatine sponge

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Michele Paolantonio

Head of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

michele paolantonio

Role: STUDY_DIRECTOR

università G. D'annunzio Chieti-Pescara

Locations

G. d'Annunzio University

Chieti, CH, Italy

Countries

Italy

Other Identifiers

072019

Identifier Type: -

Identifier Source: org_study_id