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临床试验/NCT02021331
NCT02021331终止不适用

The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Soft Tissue Diemensional Change

研究概览

简要总结

The purpose of this study is to compare two different techniques of placing dental implants: 1) removing the tooth and placing the implant immediately and 2) removing the tooth and placing both the implant and a temporary crown immediately. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best implant placement technique for their patients.

详细描述

To qualify, patients must be between 18 to 79 years old, in good health, have a tooth in the upper jaw (except molars) that needs to be extracted, and able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months). Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Patients will be excluded for any of the following conditions: Women who are pregnant or plan to become pregnant, an existing implant adjacent to the area of study, current smoker or quit smoking less than one year ago, antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition), chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...), current orthodontic treatment, or active periodontal treatment. Participants must inform the investigators if they are enrolled in any other studies because it may becloud them from participation in this study.

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
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 to 79 years old
  • in good health
  • have a single tooth in the upper jaw (except molars) that needs to be extracted
  • able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months)
  • Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

排除标准

  • an existing implant adjacent to the area of study
  • current smoker or quit smoking less than one year ago
  • antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition)
  • chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...)
  • current orthodontic treatment, or active periodontal treatment
  • Women who are pregnant or plan to become pregnant during the course of the study, and nursing mothers
  • unstable medical condition or if you are unable to have routine dental surgery then you should not participate in this study. If you are already participating in another study, we ask that you inform the investigators because participating in more than one study may be harmful to you.

结局指标

主要结局

Soft Tissue Diemensional Change

时间窗: Baseline, 12mo after baseline

Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.

次要结局

  • Implant Survival(2wk, 4wk, 6wk, 3mo, 6mo, 12mo)

研究者

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

Robert M. Eber

Principal Investigator

University of Michigan

研究点 (2)

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