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临床试验/NCT03281148
NCT03281148Unknown不适用

Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2017年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Linear Deviation

研究概览

简要总结

Patients with hopeless teeth in the esthetic area requiring immediate implant restoration will be recruited to the study. Patients will be divided into two groups; a group will receive immediate implants placed using CAD/CAM guides while the other group will receive immediate implants placed by free hand technique. Accuracy of inserted implants will be measured.

详细描述

Interventions The principal investigator (DA) will diagnose all patients and select them according to inclusion and exclusion criteria.

The principal investigator (DA) will prepare all patients. Patient preparation will take few steps that are important for optimum planning of implant insertion and restoration. Actual treatment steps will start after preparation is done including; surgical and prosthetic procedures.

  1. Case history

  2. Medical history:

The principal investigator (DA) will ask all patients about their present and previous systemic condition and any history of hospitalization or surgeries. Controlled diabetic patients will be asked to bring a recent blood glucose test. This includes both fasting/post prandial &glycosylated hemoglobin test (Hemoglobin A1c) to evaluate their current status. 2. Dental history:

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 (Participant)

入排标准

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

入选标准

  • Patients with hopeless teeth or remaining roots
  • Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)
  • Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)
  • Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)
  • Adults more than 18 years old

排除标准

  • Uncontrolled diabetic patients (HbA1c value ≥ 8.1 percent) (Takeshita et al., 1998)(Javed & Romanos, 2009)(Garg, 2010)(Retzepi & Donos, 2010)(B R Chrcanovic et al., 2014)
  • Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)
  • Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al., 2012)(Zhou et al., 2015)

研究组 & 干预措施

Computer guided implant insertion group

Experimental

According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.

干预措施: Computer guided implant insertion group (Device)

Free hand implant insertion group

Active Comparator

According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.

干预措施: Free hand implant insertion group (Device)

结局指标

主要结局

Linear Deviation

时间窗: two months postoperative

The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.

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

Doaa Mohammed Ayman

Assistant lecturer at Prosthodontic Department Faculty of Dentistry

Cairo University

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