Back to resultsPlatelet Rich Fibrin in the Treatment of Palatal Wounds
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Palatal wound bandage
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Connective Tissue Grafts, Wound healing, Biomaterials, Pain, Clinical Trials, Mucogingival Surgery
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
Sites / Locations
- G. d'Annunzio University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Palatal wound bandage by PRF
Palatal wound bandage by gelatin sponge
Arm Description
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
Intervention: The control group patients (n=20) will have their palatal wound medicated by absorbable gelatin sponge.
Outcomes
Primary Outcome Measures
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02438046
Brief Title
Platelet Rich Fibrin in the Treatment of Palatal Wounds
Official Title
Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University
4. Oversight
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Connective Tissue Grafts, Wound healing, Biomaterials, Pain, Clinical Trials, Mucogingival Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Palatal wound bandage by PRF
Arm Type
Experimental
Arm Description
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
Arm Title
Palatal wound bandage by gelatin sponge
Arm Type
Placebo Comparator
Arm Description
Intervention: The control group patients (n=20) will have their palatal wound medicated by absorbable gelatin sponge.
Intervention Type
Procedure
Intervention Name(s)
Palatal wound bandage
Intervention Description
Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.
Primary Outcome Measure Information:
Title
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound
Time Frame
four weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Paolantonio, MD; DDS
Phone
+393395204073
Email
mpaoantonio@unich.it
Facility Information:
Facility Name
G. d'Annunzio University
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Paolantonio, MD; DDS
Phone
+393395204073
Email
mpaolantonio@unich.it
12. IPD Sharing Statement
Learn more about this trial
Platelet Rich Fibrin in the Treatment of Palatal Wounds
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