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临床试验/NCT02096978
NCT02096978已完成不适用

A Randomized Controlled Clinical Study Comparing Implant Stability Using Osteotome vs. Conventional Drilling Techniques by Resonance Frequency Analysis

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Necessary stability to insert prosthesis by RFA units

研究概览

简要总结

The study will be conducted to compare two alternative techniques for dental implant placement. Both of the techniques - Osteotome and Conventional Drilling Techniques for the preparation of the implant sites (osteotomies) are accepted standards of care. The goal of the study will be to compare implant stabilities achieved with two techniques by measuring resonance frequency for each implant placed using the diagnostic device, the Osstell machine, that measures "stiffness" of the bone/implant system non-invasively. The data are represented in a quantitative value - implant stability quotient (ISQ), where a higher value indicated a higher implant stability. Since it has been well documented in the scientific literature that primary (at the time of implant placement) implant stability is a strong prerequisite for implant success (osseointegration and subsequent function on loading), the results of this study will guide the implant team in choosing the right surgical treatment protocol - the protocol that will be aimed for higher implant stability, and, therefore, for higher long-term implant success.

详细描述

With the emergence of one stage surgical approach to implant placements with immediate loading (IL), the importance of achieving uncompromised primary stability, especially in poor bone density (D3, D4), cannot be underestimated. Degidi et al. showed that poor quality bone was related to increased marginal bone loss and inferior clinical outcomes for IL implants. In a 5 year retrospective study, Elkhoury et al. found that one of the significant clinical parameters, associated with success of plasma-sprayed cylindrical dental implants was higher bone density (P<0.0001). Hermann et al evaluated 487 implants randomly selected from a research created database that used different implant placements protocols placed over a 5 year period and found out that implant failures were primarily associated with negative bone-related patient factors: jawbone quality and shape.

Two bone types that fall in the negative bone-related factors are types D3 and D4. D3 type bone, which consists of thin porous cortical and fine trabecular bone, according to the Misch bone density classification, is most prevalent in anterior maxilla and posterior regions of maxilla and mandible. In a review of 73 published articles, by Esposito et al., biological factors that contribute to failures of osseointegrated oral implants, the authors confirmed that maxillas, due to their poor bone density, have almost 3 times more implant failures than mandibles.

In planning the case, it is very important to differentiate between bone quality and bone density. Bone quality comprises bone metabolism, cell turn over, mineralization, maturation, intercellular matrix, and vascularization and while all of these factors influence implant success, it is valuable to be able to isolate them in order to be able to investigate their individual contributions to implant outcomes.

The development of three-dimensional imaging, such as Computed Tomography (CT) and Cone Beam Computed Tomography (CBCT) has recently became the standard of care during pre-surgical phase, at implant planning stage. It enables an implant team to provide the most precise and reliable diagnostic information on the patient's vital anatomy, bone quality and bone quantity at the proposed implant sites. In 95% of cases that use CT, bone quantity determination is to +/- 1 mm of accuracy, compared to only 30% of cases that use panoramic radiology.

A comprehensive review of 45 manuscripts by Molly that investigated and discussed the relationship between bone density and primary implant stability concluded that there is a significant correlation exists between bone density, primary stability, and implant outcomes.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One maxillary implant fixture per patient indicated by the treatment plan.
  • No previous implant attempted in the area
  • No previous GBR or sinus lift done
  • No GBR or sinus lift needed
  • A minimum of 7mm of horizontal bone and a minimum of 12mm of vertical height will be needed to accommodate a 4x10mm fixture.

排除标准

  • History of diabetes, HIV+, radiation therapy, smoking, oral/intravenous bisphosphonates intake.
  • Pregnant women
  • Maxillary bone density of Type D1/Type D2, as determined by a preoperative three-dimensional imaging.
  • No grafted sites.

结局指标

主要结局

Necessary stability to insert prosthesis by RFA units

时间窗: 90 days

Stability to be measured by RFA units

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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