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Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Palatal wound bandage with PRF
Palatal wound bandage with Gelatine Sponge
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • G. d'Annunzio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FULL THICKNESS PALATAL GRAFT

FREE GINGIVAL GRAFT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2019
Last Updated
March 14, 2023
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT04043039
Brief Title
Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds
Official Title
Platelet Rich Fibrin in the Treatment of Palatal Wounds After Full Thickness Palatal Grafts Harvesting: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FULL THICKNESS PALATAL GRAFT
Arm Type
Experimental
Arm Description
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
Arm Title
FREE GINGIVAL GRAFT
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Palatal wound bandage with PRF
Intervention Description
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
Intervention Name(s)
Palatal wound bandage with Gelatine Sponge
Intervention Description
palatal wound will be protected by gelatine sponge
Primary Outcome Measure Information:
Title
Time needed to obtain a complete re epithelialization of the palatal wound
Description
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michele paolantonio
Organizational Affiliation
università G. D'annunzio Chieti-Pescara
Official's Role
Study Director
Facility Information:
Facility Name
G. d'Annunzio University
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

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