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临床试验/NCT03814707
NCT03814707Unknown不适用

Clinical Comparison of Platelet Rich Fibrin Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Wound Healing After Free Gingival Graft Harvesting: A Randomized Clinical Trial

mostafa soliman1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
26
试验地点
1
主要终点
post operative pain

研究概览

简要总结

Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure .

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详细描述

  • Patients of both groups will be subjected to:
  1. Case history including personal data, medical, surgical history and family history.
  2. Clinical Examination.

After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. The free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 .

The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures.

Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was introduced by Choukroun & coworkers. PRF requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. After collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. After the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack

研究设计

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

盲法说明

both the participants and the investigator can't be blinded only outcome assessor will be blinded .

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Topical application 0.2%Hyaluronic Acid

Active Comparator

Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack

干预措施: Topical application of 0.2% hyaluronic acid gel (Drug)

Platelet Rich Fibrin

Experimental

Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.

干预措施: Platelet rich fibrin (Biological)

结局指标

主要结局

post operative pain

时间窗: 1 week

Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst

次要结局

  • wound healing(2 months)

研究者

发起方
mostafa soliman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mostafa soliman

Principle Investigator

Cairo University

研究点 (1)

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