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临床试验/NCT03689933
NCT03689933Unknown不适用

Stability of Patient-specific Root-analogue Implants and Conventional Root-form Implants for Treating Non-restorable Single-rooted Maxillary Teeth

Cairo University0 个研究点目标入组 10 人开始时间: 2018年11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
10
主要终点
implant stability

研究概览

简要总结

its a experimental study comparing between the stability of immediate root fomed implant versus the conventional titanium implant

详细描述

Patients will be selected from the out-patient clinic according to the inclusion and exclusion criteria, from where the participants will be divided into two equal groups using computer generated random table and the sequence of the random numbers will be only revealed to the Co-supervisor who will report the assigned treatment to the principal investigator.

Immediate placement of root analogue titanium dental implants. All patients in the study group will be radiographed using cone beam computed tomography for diagnosis and evaluating the attachment of the tooth and bone level.

The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed.

After all additions and adjustments are being made, an STL (stereolithography) extension file followed by milling of the implant from medically grade titanium will be carried out, followed by sandblasting acid etching.

For sterilization, the implant will be washed in a 90% concentration ethanol ultrasonic bath for 10 minutes, followed by packaging and sterilizing in a steam pressure autoclave.

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
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Single rooted teeth indicated for extraction and immediate implant placement.
  • •The age of candidates ranges from 21 to 50 years.

排除标准

  • •Absence of any disease or systemic complication which might affect osseointegration.
  • •The cause of extraction mustn't be due to periodontitis or periapical infection.

研究组 & 干预措施

root analog implant

Experimental

The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed.

干预措施: Root analog implant (Device)

conventional stock root-form titanium implant

Active Comparator

Using a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth.

干预措施: Root analog implant (Device)

结局指标

主要结局

implant stability

时间窗: 6 months

using periotest

次要结局

未报告次要终点

研究者

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

Amr mohamed ahmed

assistant lecturer

Cairo University

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