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临床试验/NCT05347017
NCT05347017Unknown不适用

The Effect of Autogenous Demineralized Dentin Block Graft Versus Autogenous Bone Block Graft on Alveolar Ridge Preservation: 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6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Alveolar ridge bucco-lingual width 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 block graft (ADDBG) versus autogenous bone block graft (ABBG) harvested from maxillary tuberosity on alveolar ridge preservation after extraction of non-restorable 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. A broadly recognized approach is the maintenance of bone walls through bone substitute (graft) delivery into the socket, where guided bone regeneration may be a requisite. Autogenous bone graft has osteogenic and osteoinductive effect. however, when attempts were made to use autologous bone chips in socket preservation, they failed to promote healing or stimulate hard tissue formation in the socket. On the other hand, autogenous bone block graft from the tuberosity has shown a feasible, user-friendly, low-cost solution for minimizing soft and hard tissue collapse and dimensional loss following single-rooted tooth extraction.

Moreover, root dentin block is composed of Type I collagen matrix with several osteoinductive non-collagenous proteins such as bone morphogenetic proteins (BMP) and dentin matrix proteins. Geometrically, alveolar bone morphology was maintained by dentin block graft as well as it has micropores (dentinal tubules) of 3-5 μm diameter and macropores of 0.2-0.3 mm diameter for enhancing osteoinductive and osteoconductive functions.

Both demineralized dentin block and autogenous bone block grafts has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear

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
是

入选标准

  • •Non-restorable tooth indicated for extraction
  • •Single-rooted teeth
  • •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...)

研究组 & 干预措施

Alveolar ridge preservation using autogenous demineralized dentin block graft

Experimental

Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using HCL acid as demineralized dentin block graft and inserted in the extraction socket

干预措施: Alveolar ridge preservation using autogenous demineralized dentin block graft (Procedure)

Alveolar ridge preservation using autogenous bone block graft

Active Comparator

Atraumatic extraction of non-restorable teeth, then autogenous bone block will be harvested from the maxillary tuberosity and reshaped and inserted in the extraction socket

干预措施: Alveolar ridge preservation using autogenous bone block graft (Procedure)

结局指标

主要结局

Alveolar ridge bucco-lingual width change in mm

时间窗: 6 months

Alveolar bone linear width will be measured at baseline and after 6 months using cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be measured in millimetres (Jung et al., 2013)

次要结局

  • Alveolar ridge apico-coronal height 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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