Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.
研究概览
地位
详细说明
This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.
Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.
The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa College of Dentistry
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years of age or greater
- Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
- Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
- An opposing dentition with teeth, implants, or fixed prosthesis
- Subjects must be willing to follow instructions related to the study procedures
- Subjects must have read, understood, and signed the informed consent document
Exclusion Criteria:
Exclusion Criteria:
- Insufficient interocclusal space for implant placement and/or restoration at study site
- More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
- Untreated rampant caries
- Tobacco use free for ≤ 6 months
- Liver or kidney disfunction/failure
- Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
- Uncontrolled diabetes
- Current alcohol or drug abuse
- Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- History of relevant head/neck cancer and/or radiation of the head/neck
- Subjects who currently use bisphosphonates or have a history of bisphosphonate use
- Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
- Known pregnancy or nursing mothers
- Unable or unwilling to return for follow-up visits for a period of 1 year
- Unlikely to be able to comply with study procedures according to investigators judgement
学习计划
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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有源比较器：Divergent Abutment
Divergent Transition Profile
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An Atlantis abutment is delivered with a linear transition profile
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实验性的：Concave Abutment
Concave Transition Profile
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An Atlantis abutment is delivered with a concave transition profile.
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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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Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
大体时间：Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
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Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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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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Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
大体时间：Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
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Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
大体时间：Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery.
This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
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Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
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合作者和调查者
调查人员
- 首席研究员：Christopher A Barwacz, DDS、University of Iowa
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 201302798
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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