Platelet Rich Fibrin in the Treatment of Palatal Wounds

NCT02438046 | Unknown Phase 4

• 1 other identifier: 1/2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Connective Tissue Grafts; Wound healing; Biomaterials; Pain; Clinical Trials; Mucogingival Surgery

Outcome Measures

Primary Outcomes (1)

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

  four weeks

Study Arms (2)

Palatal wound bandage by PRF

EXPERIMENTAL

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

Procedure: Palatal wound bandage

Palatal wound bandage by gelatin sponge

PLACEBO COMPARATOR

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

Procedure: Palatal wound bandage

Interventions

Palatal wound bandage PROCEDURE

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

Palatal wound bandage by PRF; Palatal wound bandage by gelatin sponge

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Gingival Recession; Pain

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michele Paolantonio, MD; DDS

CONTACT

+393395204073; mpaoantonio@unich.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

IT (1)