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临床试验/NCT03985033
NCT03985033已完成不适用

The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial

The European Research Group on Periodontology (ERGOPerio)1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Concentrations changes of the molecules and inflammatory mediators

研究概览

简要总结

This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on post-extraction sockets healing.

详细描述

Tooth extraction is one of the most frequent dental surgical procedures. Following tooth extraction, dimensional changes of the alveolus are inevitable, which consequently decrease the height and width of alveolar bone and impair ideal implant placement and conventional prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from blood. PRF not only supports hemostasis but also favors the natural wound healing process. Over the past decade, PRF has gained tremendous momentum having been utilized for a variety of dental and medical procedures including the management of post-extraction sockets. To date, several studies have assessed the efficacy of the use of PRF in promoting postextraction sockets healing. However, results remain contradictory and mainly focus on the clinical and radiological hard and soft tissue healing, aesthetics and postoperative discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations modulate the wound healing process but the effect of local PRF application on the kinetics of release of wound healing modulators has not been studied so far. There is also a lack of information in the literature regarding the biological evaluation during postextraction sockets healing to understand the potential mechanisms. In order to assess the presence or follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows simultaneous quantification of multiple markers providing unique information for a more complete understanding of the potential mechanism of PRF and spontaneous extraction socket healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of PRF on biomarkers response during post-extraction sockets healing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study
  • Healthy males and females of age 18-70
  • Need for two or more extractions of single rooted teeth in the presence of adjacent teeth or implants due to unrestorable caries, residual roots, root fractures or orthodontic treatment
  • Able (in the investigators opinion) and willing to comply with all study requirements
  • Interested in tooth replacement with dental implants

排除标准

  • Endodontic periapical lesions with a diameter of more than 5 mm (radiographically determined)
  • Sites with buccal and lingual bone plate loss more than 5 mm
  • Frank purulence or acute abscess at the time of extraction
  • Pregnancy or lactation
  • Smokers or alcoholics
  • Platelet dysfunction syndrome or thrombocytopenia
  • Uncontrolled diabetes
  • Medical contraindications to elective oral surgery procedures

结局指标

主要结局

Concentrations changes of the molecules and inflammatory mediators

时间窗: Baseline, 6 hours, 24 hours, 3 days and 7 days

Concentrations changes of the molecules and inflammatory mediators in the gingival crevicular fluid (GCF) or wound fluid (WF) from the extraction sockets in L-PRF group and control group at baseline (from GCF), 6 hours, 24 hours, 3 days, 7 days.

次要结局

  • Genes expression profiles(Baseline and 3 days)
  • Radiographic bone changes (Cone-beam computed tomography)(Baseline and 4 months)
  • Wound Healing Index (HI)(6 hours, 24 hours, 3 days and 7 days)
  • Laser Doppler Flowmetry (LDF) measurement(Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days)
  • Visual analog scale (VAS)(6 hours, 24 hours, 3 days and 7 days)

研究者

发起方
The European Research Group on Periodontology (ERGOPerio)
申办方类型
Network
责任方
Principal Investigator
主要研究者

Maurizio Tonetti

Executive Director, Clinical Professor

The University of Hong Kong

研究点 (1)

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