The Clinical Performance of Inlay Zirconia Bridges
2018年9月9日 更新者：Damascus University
The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs
When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. The development use of zirconia technology and all-ceramic systems has opened the potential for fabrication inlays zirconia bridges with durability and good aesthetics.
The purpose of this study is to clinically evaluate the placement of inlay bridge made of a Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive approach in the replacement of a single missing tooth.
研究概览
详细说明
This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with three designs in the replacement process of one single tooth (i.e. a missing premolar or molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press.
The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with glaze layer to improve the adhesion.
The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with a layer of e-max ceramic press to improve the adhesion.
研究类型
介入性
注册 (实际的)
30
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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Damascus、阿拉伯叙利亚共和国、DM20AM18
- Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
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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
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Good oral hygiene
- Low susceptibility to caries
- Parallel alignment of abutment teeth
- Immobility of the abutment teeth
- Minimum height of abutment teeth ≥ 5 mm (connector thickness)
- Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or 12 mm (width of molar)
Exclusion Criteria:
- Severe para-functional habits.
- Short clinical crowns (<5 mm)
- Extensive defects of the clinical crown,
- Loosening of teeth because of factors related to the periodontal tissues.
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Zirconia and E-max Press
The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
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实验性的：Zirconia and E-max Press and Glaze
The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.
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A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
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实验性的：Zirconia and E-max Press twice
The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.
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A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
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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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Change in marginal fit
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Material Integrity
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in the Retention Status
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The resistance of a prosthesis to displacement will be measured.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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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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Change in Marginal Color Matching
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Change in Sensitivity
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The presence of any spontaneous or stimulated pain will be assumed.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Patients' Satisfaction
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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A questionnaire will be used to detect the level of satisfaction regarding function and shade
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Shade
大体时间：Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The shade is going to be determined using Vita(R) shade guide.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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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
- 首席研究员：Mansour Abo Alkasab, DDS MSc、PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
- 研究主任：Jihad Abo Nassar, DDS MSc PhD、Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
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
- Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.
- Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.
- Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.
- Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.
- Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.
- Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.
- Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.
- Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.
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 (实际的)
2016年6月1日
初级完成 (实际的)
2018年1月15日
研究完成 (实际的)
2018年8月15日
研究注册日期
首次提交
2016年12月14日
首先提交符合 QC 标准的
2016年12月14日
首次发布 (估计)
2016年12月19日
研究记录更新
最后更新发布 (实际的)
2018年9月11日
上次提交的符合 QC 标准的更新
2018年9月9日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
其他研究编号
- UDDS-FixPro-02-2016
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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.
Glaze layer的临床试验
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Integra LifeSciences CorporationSt Vincent's Hospital完全的