An interventional study of connective tissue graft and connective tissue graft&PRF in Wound Healing, Pain, Postoperative and Bleeding Wound, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by Pamukkale University · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Drug:local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: * 5/0 silk suture
Procedure: connective tissue graft · Procedure: connective tissue graft&PRF · Other: connective tissue graft&PRF
Drug: local anesthesia (2% lidocaine with 1:100,000 epinephrine/ultracaine ds ampule) Other names: -5/0 silk suture
Procedure: connective tissue graft · Procedure: connective tissue graft&PRF · Other: connective tissue graft&PRF
* anesthesia of the palatal mucosa * subepithelial connective tissue graft harvesting * suturing (5/0 silk suture)
anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting -suturing (5/0 silk suture)
* taking blood from patient * centrifuging blood * obtain PRF
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
Time frame: 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'
Time frame: 10 days
postoperative bleeding
Patients were told to record DB, 'present' or 'absent' in a 7-day postoperative period.
Time frame: 7days
Tissue colour match
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
Plan to share: No
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Pamukkale University