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临床试验/NCT02416700
NCT02416700已完成不适用

Evaluation of Peri Implant Bone Loss of Immediately Loaded Versus Conventionally Loaded Implants With a Single Prosthesis: A Randomized and Clinical Study Split-mouth Experimental Design

Mônica Nogueira Pigozzo2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Bone Loss of Immediate Versus Conventional Implants as determined by x-ray evaluation

研究概览

简要总结

The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain.

详细描述

The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain. These data will be collected for both the control/delayed loading group and the test/immediate loading group, followed by statistical analysis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • edentulous sites bilateral in maxilla and mandibula with adequate quantity of bone

排除标准

  • Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research

研究组 & 干预措施

immediate implant surgery

Experimental

Immediate implant surgery in one site.

干预措施: immediate implant surgery (Procedure)

conventional implant surgery

Active Comparator

Conventional implant surgery in another site

干预措施: implant surgery (Straumann®) (Device)

结局指标

主要结局

Bone Loss of Immediate Versus Conventional Implants as determined by x-ray evaluation

时间窗: 12 months

The same bone loss of for conventional and immediate implants.

次要结局

  • The success rate of the installed implants will be determined(12 months)

研究者

发起方
Mônica Nogueira Pigozzo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mônica Nogueira Pigozzo

Student

University of Sao Paulo

研究点 (2)

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