Back to resultsPRF for Accelerating Palatal Healing
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Rich Fibrin
Butyl cyanoacrylate
Wet gauze
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- no contraindications for periodontal surgery;
- full-mouth plaque score of <10%
- full-mouth bleeding score of <15%.
Exclusion Criteria:
- previously undergone surgery for a graft harvested from the palate
- presence of systemic disease or taking medication known to interfere with periodontal health
- smokers
- possible coagulation disorders
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Platelet Rich Fibrin
Butyl cyanoacrylate
Wet Gauze
Arm Description
PRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized
Butyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft
Wet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft
Outcomes
Primary Outcome Measures
Epithelialization
Assessed according to the toluedine blue coloring
Secondary Outcome Measures
Sensibility disorders
visual analogue scale scores
feeding habits
visual analogue scale scores
Delayed bleeding
Bleeding assesment for post-operative one week
Immediate Bleeding
Bleeding assesment for post-operative one hour
Pain
Visual Analague Scale scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02712242
Brief Title
PRF for Accelerating Palatal Healing
Official Title
The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.
Detailed Description
125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.
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
Investigator
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
PRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized
Arm Title
Butyl cyanoacrylate
Arm Type
Active Comparator
Arm Description
Butyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft
Arm Title
Wet Gauze
Arm Type
Placebo Comparator
Arm Description
Wet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft
Intervention Type
Other
Intervention Name(s)
Platelet Rich Fibrin
Intervention Description
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
Intervention Type
Other
Intervention Name(s)
Butyl cyanoacrylate
Intervention Description
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
Intervention Type
Other
Intervention Name(s)
Wet gauze
Intervention Description
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.
Primary Outcome Measure Information:
Title
Epithelialization
Description
Assessed according to the toluedine blue coloring
Time Frame
One month
Secondary Outcome Measure Information:
Title
Sensibility disorders
Description
visual analogue scale scores
Time Frame
One month
Title
feeding habits
Description
visual analogue scale scores
Time Frame
One month
Title
Delayed bleeding
Description
Bleeding assesment for post-operative one week
Time Frame
1 week
Title
Immediate Bleeding
Description
Bleeding assesment for post-operative one hour
Time Frame
1 hour
Title
Pain
Description
Visual Analague Scale scores
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no contraindications for periodontal surgery;
full-mouth plaque score of <10%
full-mouth bleeding score of <15%.
Exclusion Criteria:
previously undergone surgery for a graft harvested from the palate
presence of systemic disease or taking medication known to interfere with periodontal health
smokers
possible coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Ozcelik, Ph D
Organizational Affiliation
Cukurova University, Professor
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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PRF for Accelerating Palatal Healing
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