Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing
Primary Purpose
Wound Healing, Pain, Postoperative, Bleeding Wound
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
connective tissue graft
connective tissue graft&PRF
connective tissue graft&PRF
Sponsored by
About this trial
This is an interventional prevention trial for Wound Healing focused on measuring connective tissue graft, platelet rich fibrin, patient perceptions, VAS
Eligibility Criteria
Inclusion Criteria:
- who needed connective tissue graft for treating gingival recessions were included
Exclusion Criteria:
- Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
- smoking,
- nausea
- pregnancy/lactation
Sites / Locations
- Pamukkale University Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
connective tissue graft
connective tissue graft&PRF
Arm Description
Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: 5/0 silk suture
Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture
Outcomes
Primary Outcome Measures
Defining wound healing to 40 patient with early healing index
to inspect the early wound healing on donor site on palate using early healing index on 3rd, 7th and 14th postoperatively. (1) complete flap closure, no fibrin line in the interproximal area; (2) complete flap closure, fine fibrin line in the interproximal area; (3) complete flap closure, fibrin clot in the interproximal area; (4) incomplete flap closure, partial necrosis of the interproximal tissue; and (5) incomplete flap closure, complete necrosis of the interproximal tissue
postoperative pain
Patients were instructed to complete pain diary for the day at the surgery, first day, third day, seventh day, tenth day after surgery. The visual analog scale (VAS) that consists of a 10-cm line anchored by 2 extremes was used for perception measurements . Total score was 100 and less score was 0 according to this scale. According to this scale "0" means no pain, no discomfort during chewing and speaking, while the "100",meant 'worst pain, extreme discomfort during chewing and speaking'
Secondary Outcome Measures
postoperative bleeding
Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.
Full Information
NCT ID
NCT03734328
First Posted
November 3, 2018
Last Updated
November 7, 2018
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT03734328
Brief Title
Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing
Official Title
Platelet Rich Fibrin Accelerates Wound Healing and Reduces Postoperative Complications of Palatal Subepithelial Connective Tissue Donor Site: a Controlled Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subepithelial connective tissue graft (SCTG) has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues. Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia. Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement.Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after a subepithelial connective tissue graft procedure at palatal donor site.
Detailed Description
Successful treatment of gingival recession (GR) is based on the use of clinically predictable periodontal plastic surgery (PPS) procedures. There are many procedures and different surgical procedures were proposed. Coronally advanced flap and subepithelial connective tissue graft (SCTG) is a good combination to increase the keratinized tissue width and reduce the amount of gingival recession.
SCTG has greater predictability for root coverage and causes minimal discomfort to patient. Although donor site heals with primary intention causing less scar tissue, in some different harvesting procedures primary flap closure may not be achieved due to nature of thick palatal tissues.
Some potential complications may occur at donor site such as: necrosis of graft and palatal site, pain, excessive hemorrhage, protracted discomfort, donor site infection and in some cases donor site paresthesia.
Platelet rich fibrin (PRF) is a platelet concentrate obtained by a simple procedure that does not require biochemical blood involvement. The three-dimensional fibrin network and presence of many growth factors such as fibroblast growth factor, platelet-derived growth factor (PDGF) and epidermal growth factor supports effective neovascularization, accelerated wound closure and rapid cicatricial tissue remodeling. The strong fibrin architecture distinguishes it from other kinds of platelets concentrates and it seems responsible for the slow release of growth factors over a period of 7-14 days5. This period is seen as sufficient to prevent complications after connective tissue graft. Since the first description by Choukroun in 2000, PRF has been used in the clinical field for more than a decade in oral surgery and implant dentistry.
Based on the known biological effects of PRF, the aim of this study is to evaluate the PRF in the management of soft tissue donor sites in term of bleeding and pain sensation, and to observe the changes in tissue healing after connective tissue graft procedure at palatal donor site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Pain, Postoperative, Bleeding Wound
Keywords
connective tissue graft, platelet rich fibrin, patient perceptions, VAS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
connective tissue graft
Arm Type
Active Comparator
Arm Description
Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)
Other names:
5/0 silk suture
Arm Title
connective tissue graft&PRF
Arm Type
Experimental
Arm Description
Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule)
Other names:
-5/0 silk suture
Intervention Type
Procedure
Intervention Name(s)
connective tissue graft
Intervention Description
anesthesia of the palatal mucosa
subepithelial connective tissue graft harvesting
suturing (5/0 silk suture)
Intervention Type
Procedure
Intervention Name(s)
connective tissue graft&PRF
Intervention Description
anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting
-suturing (5/0 silk suture)
Intervention Type
Other
Intervention Name(s)
connective tissue graft&PRF
Intervention Description
taking blood from patient
centrifuging blood
obtain PRF
Primary Outcome Measure Information:
Title
Defining wound healing to 40 patient with early healing index
Description
to inspect the early wound healing on donor site on palate using early healing index on 3rd, 7th and 14th postoperatively. (1) complete flap closure, no fibrin line in the interproximal area; (2) complete flap closure, fine fibrin line in the interproximal area; (3) complete flap closure, fibrin clot in the interproximal area; (4) incomplete flap closure, partial necrosis of the interproximal tissue; and (5) incomplete flap closure, complete necrosis of the interproximal tissue
Time Frame
14 days
Title
postoperative pain
Description
Patients were instructed to complete pain diary for the day at the surgery, first day, third day, seventh day, tenth day after surgery. The visual analog scale (VAS) that consists of a 10-cm line anchored by 2 extremes was used for perception measurements . Total score was 100 and less score was 0 according to this scale. According to this scale "0" means no pain, no discomfort during chewing and speaking, while the "100",meant 'worst pain, extreme discomfort during chewing and speaking'
Time Frame
10 days
Secondary Outcome Measure Information:
Title
postoperative bleeding
Description
Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.
Time Frame
7days
Other Pre-specified Outcome Measures:
Title
Tissue colour match
Description
On days 3, 7, 14 , the color of the palatal mucosa was assessed by the VAS score with the adjacent and opposite mucosa color. In this evaluation, 0 points showed no color matching, and 100 points showed excellent color matching with evaluated tissues
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
who needed connective tissue graft for treating gingival recessions were included
Exclusion Criteria:
Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
smoking,
nausea
pregnancy/lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat AKGUL, prof. dr.
Organizational Affiliation
Pamukkale University Faculty of Dentistry Department of Periodontolgy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University Faculty of Dentistry
City
Denizli
State/Province
Deni̇zli̇
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16504852
Citation
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
Results Reference
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PubMed Identifier
26313017
Citation
Femminella B, Iaconi MC, Di Tullio M, Romano L, Sinjari B, D'Arcangelo C, De Ninis P, Paolantonio M. Clinical Comparison of Platelet-Rich Fibrin and a Gelatin Sponge in the Management of Palatal Wounds After Epithelialized Free Gingival Graft Harvest: A Randomized Clinical Trial. J Periodontol. 2016 Feb;87(2):103-13. doi: 10.1902/jop.2015.150198. Epub 2015 Aug 27.
Results Reference
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Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing
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