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Clinical Trials/NCT04043039
NCT04043039
Completed
N/A

Platelet Rich Fibrin in the Treatment of Palatal Wounds After Full Thickness Palatal Grafts Harvesting: A Randomized Clinical Trial

G. d'Annunzio University1 site in 1 country80 target enrollmentSeptember 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
G. d'Annunzio University
Enrollment
80
Locations
1
Primary Endpoint
Time needed to obtain a complete re epithelialization of the palatal wound
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2019
End Date
November 4, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Michele Paolantonio

Head of Periodontology

G. d'Annunzio University

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

Outcomes

Primary Outcomes

Time needed to obtain a complete re epithelialization of the palatal wound

Time Frame: 4 weeks

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

Study Sites (1)

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