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临床试验/NCT02401789
NCT02401789进行中(未招募)不适用

Dimensional Alterations of the Edentulous Ridge Following Removal of Multiple Adjacent Teeth

Institute Franci2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

研究概览

简要总结

The objective of the present study is to evaluate if loss of multiple adjacent teeth will cause proportionally greater tissue diminution than the loss of single teeth the possibility of counteracting unfavourable ridge modeling after multiple tooth extractions by placing implants in the fresh extraction sites soft tissue alterations at implants and adjacent teeth

详细描述

The study will be designed as a prospective, randomized, controlled multicenter study evaluating the potential of endosseous implants (OsseospeedTM,EV, Astra Tech System, DentsplyTM, Mölndal, Sweden) placed in fresh extraction sockets to preserve the ridge dimensions at the edentulous site.

Three centers will be involved in the study namely, (i) Department of Periodontology, University of Padova, Italy, (ii) Institute Franci, Padova, Italy, (iii) Department of Periodontology, Sahlgrenska Academy, University of Gothenburg, Sweden.

Prior to the start of the study the human review board at the treatment centers must approve the study protocol as well as the informed consent forms.

Group assignment

Following the removal of the target teeth, the subject (site) will be randomly assigned to one of 2 groups:

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
25 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • presence of an intact extraction socket following removal of the natural teeth defined by: a marginal dehiscence defect of the facial bone wall of < 3 mm no facial fenestration present apical of the marginal bone crest

排除标准

  • Untreated rampant caries and uncontrolled periodontal disease Uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing Unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.

结局指标

主要结局

Measurements of the change of the bone in between 2 or more teeth reported in millimeters after 6 month of the extraction in relation to the amount of the buccal-lingual reduction

时间窗: 5 year

次要结局

未报告次要终点

研究者

发起方
Institute Franci
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecchinato Denis

Dimensional alterations of the edentulous ridge following removal of multiple adjacent teeth.

Institute Franci

研究点 (2)

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