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临床试验/NCT03479333
NCT03479333Unknown不适用

Short vs Standard Implants in Maxilla: a Randomized Clinical Trial

Federal University of Pelotas2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
implant survival

研究概览

简要总结

The prosthetic treatment with dental implants is challenging in posterior maxilla, where there is a sinus pneumatization. For the rehabilitation of patients with intermediate bone level, short implants have been used as alternative. It is also needed to look for the prosthetic context of rehabilitation with implants, like the use of different materials as abutments. The aim of this study is to compare the survival of two sizes of implants (short vs standard) placed in upper premolars region with need of bone graft, with a minimum of three years of follow-up, and assess the behavior of different abutments (titanium vs zirconia) in prosthesis in this context. This will be a randomized clinical trial with two groups: 1) standard implants and sinus lift; and 2) short implants without sinus lift. The patients who fulfill the inclusion criteria and accept to participate of this study, will be included in the randomization process. At the implant installation, a brown envelope, with the word SHORT or STANDARD, will be open, in order to determine the group. Abutment type will be also randomized. Four months after the installation, torque will be confirmed and the abutment will be installed. Implant failure and prosthesis failure in function of the abutment will be the outcomes. Data analysis will be conducted following a previously established spreadsheet using the Kaplan-Meier method and log rank test for success and survival, followed by Cox regression, if possible and according to the number of failures.

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
Double (Participant, 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

  • good general and dental health;
  • minimum of 6 mm bone width (BP);
  • bone height in sinus region between 5 and 9 mm;
  • bilateral posterior occlusal contact.

排除标准

  • removable or partial denture;
  • patient with systemic disease treatment in course;
  • pregnant women;
  • recent extraction at the site to receive the implant.

结局指标

主要结局

implant survival

时间窗: five months after the implant placement

survival will be evaluated by osseointegration presence.

次要结局

未报告次要终点

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximiliano Sergio Cenci

Professor

Federal University of Pelotas

研究点 (2)

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