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临床试验/NCT04731545
NCT04731545已完成不适用

Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Bucccal bone changes

研究概览

简要总结

The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

详细描述

With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients.

Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure.

Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
  • •Healthy systemic condition.
  • •Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
  • •Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
  • •Good oral hygiene.
  • •Patient accepts a minimum of three-year follow-up period (cooperative patients).

排除标准

  • •Signs of acute infection related to the area of interest.
  • •Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
  • •Smokers (Lambert et al. 2000).
  • •Pregnant females.

研究组 & 干预措施

thin buccal bone

Active Comparator

干预措施: immediate implant placement (Device)

thick buccal bone

Active Comparator

干预措施: immediate implant placement (Device)

结局指标

主要结局

Bucccal bone changes

时间窗: 12 months post loading

standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm

次要结局

  • Crestal bone changes(12 months post loading)
  • Soft tissue thickness(3 months)
  • Post operative pain and swelling(1 week)
  • Pink aesthetic score(12 months post loading)
  • Buccal bone thickness(3 months)
  • Postsurgical satisfaction(1 week)
  • Implant stability(3 months)

研究者

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

Hani Elnahass

Assitant Professor

Cairo University

研究点 (1)

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