Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
2020年5月7日 更新者：Dentsply Sirona Implants and Consumables
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.
The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
研究概览
研究类型
介入性
注册 (实际的)
97
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Victoria
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Melbourne、Victoria、澳大利亚、3010
- School of Dental Science, University of Melbourne
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Göteborg、瑞典、SE 405 30
- Dept. of Parodontology, Göteborg University
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California
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Los Angeles、California、美国、90089-0641
- USC School of Dentistry
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Iowa
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Iowa City、Iowa、美国、52242-1010
- The University of Iowa, College of Dentistry
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London、英国、SE1 9RT
- King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
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Apeldoorn、荷兰、7315
- Praktijk De Mondhoek
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
- Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group-1, Implant length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
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OsseoSpeed™ dental implant, length: 6 mm
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其他：Group-2, Implant length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
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OsseoSpeed™ dental implant, length: 11 mm
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Radiological Assessments of Marginal Bone Level Alteration
大体时间：Evaluated from implant installation to 5 years follow-up after implant placement
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Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. |
Evaluated from implant installation to 5 years follow-up after implant placement
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Overall Implant Survival
大体时间：Evaluated 5 years after implant placement
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Overall implant survival, measured on implant level
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Evaluated 5 years after implant placement
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Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
大体时间：Measured at the 5-year follow-up visit after loading
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Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP).
Presented as s count of implants that show presence of BoP.
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Measured at the 5-year follow-up visit after loading
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Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
大体时间：Evaluated at implant loading and at the 5-year follow-up visit.
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Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
Evaluated at implant loading and at the 5-year follow-up visit.
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Presence of Plaque
大体时间：Evaluated at the 5-year follow-up visit after loading.
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Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. |
Evaluated at the 5-year follow-up visit after loading.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Anna-Karin Lundgren、Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
- Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2007年10月16日
首先提交符合 QC 标准的
2007年10月16日
首次发布 (估计)
2007年10月17日
研究记录更新
最后更新发布 (实际的)
2020年5月19日
上次提交的符合 QC 标准的更新
2020年5月7日
最后验证
2020年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.