Evaluation of the Effects of Platelet Rich Fibrin on the Palatal Mucosal Healing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet Rich Fibrin Accelerates Wound Healing and Reduces Postoperative Complications of Palatal Subepithelial Connective Tissue Donor Site: a Controlled Randomized Clinical Trial

Conditions
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Wound Healing, Pain, Postoperative, Bleeding Wound

Intervention / Treatment
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* Procedure: connective tissue graft
* Procedure: connective tissue graft&PRF
* Other: connective tissue graft&PRF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: connective tissue graft<br>Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: 5/0 silk suture | Procedure: connective tissue graft<br>* anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting suturing (5/0 silk suture)<br>Procedure: connective tissue graft&PRF<br>* anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture)<br>Other: connective tissue graft&PRF<br>* taking blood from patient centrifuging blood obtain PRF<br>|
| Experimental: connective tissue graft&PRF<br>Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture | Procedure: connective tissue graft<br>* anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting suturing (5/0 silk suture)<br>Procedure: connective tissue graft&PRF<br>* anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture)<br>Other: connective tissue graft&PRF<br>* taking blood from patient centrifuging blood obtain PRF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 
| 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' | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding | Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period. | 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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connective tissue graft, platelet rich fibrin, patient perceptions, VAS