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Clinical Trials/NCT02438046
NCT02438046
Unknown
Phase 4

Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial

G. d'Annunzio University1 site in 1 country40 target enrollmentMay 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
G. d'Annunzio University
Enrollment
40
Locations
1
Primary Endpoint
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
G. d'Annunzio University
Responsible Party
Principal Investigator
Principal Investigator

Michele Paolantonio

Full time professor

G. d'Annunzio University

Eligibility Criteria

Inclusion Criteria

  • are as follows:
  • 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

Outcomes

Primary Outcomes

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

Time Frame: four weeks

Study Sites (1)

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