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临床试验/NCT03734328
NCT03734328已完成不适用

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

Pamukkale University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • who needed connective tissue graft for treating gingival recessions were included

排除标准

  • Patients with systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy),
  • pregnancy/lactation

结局指标

主要结局

postoperative pain

时间窗: 10 days

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'

Defining wound healing to 40 patient with early healing index

时间窗: 14 days

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

次要结局

  • postoperative bleeding(7days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AYSAN LEKTEMUR ALPAN

Assistant Proffessor

Pamukkale University

研究点 (2)

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