Platelet Rich Fibrin in the Treatment of Palatal Wounds

NCT ID: NCT02438046

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-06-30

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.

Conditions

Gingival Recession

Study Design

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

Study Groups

Palatal wound bandage by PRF

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

Group Type: EXPERIMENTAL

Palatal wound bandage

Intervention Type: PROCEDURE

Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.

Palatal wound bandage by gelatin sponge

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

Group Type: PLACEBO_COMPARATOR

Palatal wound bandage

Intervention Type: PROCEDURE

Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.

Interventions

Palatal wound bandage

Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin 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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Michele Paolantonio

Full time professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

G. d'Annunzio University

Chieti, CH, Italy

Countries

Italy

Central Contacts

Michele Paolantonio, MD; DDS

Role: CONTACT

mpaoantonio@unich.it

+393395204073

Facility Contacts

Michele Paolantonio, MD; DDS

Role: primary

mpaolantonio@unich.it

+393395204073

Other Identifiers

1/2015

Identifier Type: -

Identifier Source: org_study_id