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临床试验/NCT05470673
NCT05470673尚未招募不适用

The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Alveolar ridge apico-coronal height change in mm

研究概览

简要总结

The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth

详细描述

Many studies have reported an approximately 50% reduction in alveolar bone both the horizontal and vertical directions over 12 months with more than two-thirds of the reduction occurring in the first three months after extraction. Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. During the last decade, efforts have been made to confirm procedures that can prevent bone resorption after extraction. The use of bone grafts aim to promote bone healing and assist bone regeneration. Various types of materials are used for socket preservation, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials.

Dentin contains several growth factors, including transforming growth factor beta (TGF-β), insulin-like growth factor-II (IGF-II) and bone morphogenetic protein-2 (BMP-2), which could be of pivotal importance during any healing event. Demineralization of dentin has been further proposed to expose its collagen matrix, liberate 'fossilized' growth factors and thereby enhance its regenerative capacity.

It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months, with no adverse effects.

The efficacy of platelet rich fibrin (PRF) in promoting wound healing and tissue regeneration is at the center of a recent academic debate. The liquid fibrinogen has been shown to bind particulate bone grafts, which are then called "sticky bone". This binding improves the stabilization of the particles in the defect. It adds a potential biological effect, which could accelerate the soft tissue healing process and optimize the handling properties of the granules.

The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin (I-PRF) to an adherent, tooth-derived conglomerate for socket preservation. Moreover, Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F. nucleatum and S. aureus.

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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non-restorable tooth indicated for extraction
  • Single-rooted teeth
  • Inactive infection related to the tooth
  • Motivated patients, agree to sign informed consent and complete the follow-up period

排除标准

  • Pregnant females
  • Active infection at extraction site
  • Systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

结局指标

主要结局

Alveolar ridge apico-coronal height change in mm

时间窗: 6 months

Difference in height linear measurements between baseline and final CBCT scans

次要结局

  • Alveolar ridge bucco-lingual width change in mm(6 months)
  • Histological assessment(6 months)

研究者

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

Mohamed Talaat Mohamed Mahmoud El Behwashy

Principal Investigator. Mohamed Elbehwashy

Cairo University

研究点 (1)

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