One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns

赞助:

合作者:

信息的提供 (责任方):

Aya Ezzat Mohamed Ali El-shimy，Cairo University

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

October 1, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Fracture[ Time Frame: one year ]

Fracture of the single crowns assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delta)

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Marginal adaptation[ Time Frame: one year ]
Marginal adaptation assessed by modified Ryge criteria (Alpha, Bravo, Charlie and Delt

描述性信息

简略标题 ^ICMJE

One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns

正式标题 ^ICMJE

One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns (Randomized Controlled Clinical Trial)

简要概况

The clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns are questionable as the peek is considered as a new material and need to be tested for future clinical application.

详细说明

The study is held to evaluate the clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns after one year follow-up. Patients requiring posterior single crowns are collected. After teeth preparation to receive single full coverage crowns, secondary impressions were taken. The patients were divided randomly into two groups ;one group will receive pressed BioHPP PEEK single crowns (the intervention) and the other group will receive veneered zirconia single crowns (the control). Fracture of restorations (1ry outcome) using modified Ryge criteria and the marginal adaptation (2ry outcome) using modified Ryge criteria and finally the patient satisfaction (3ry outcome) using a questionnaire, all outcomes will be evaluated every 2 months with total period of follow-up of one year.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: patients requiring posterior single crowns.
盲法: Interventional
盲法描述:Double blinding (trial participants and outcome assessor) Dental colleague assessors who are blinded about the aim of the study and participant's allocation will be responsible for assessing the outcomes of this study. The level of intra- and inter-examiner reliability will be determined for each assessor by the performance of a calibration session prior to the start of the trial. A training exercise to the assessors with the main investigator will help to standardize measurement techniques and parameters. An interactive calibration session will enable the investigator to quantitate the measurement variability among and between assessors and enable the optimization of the measurement process. The main supervisor will solve any conflict that may arise between the assessors by repeating the assessing and giving the final opinion.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: BioHPP PEEK single posterior crowns
BioHPP is a 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymeric material, used for fabrication of high strength fixed and removable prostheses. it has advantages of bio-compatibility, low density, light weight, shock absorption.
Other: zirconia-based single posterior crowns
ZrO2, a ceramic material used for medical devices, displays good esthetic appearance, high mechanical strength, and high biocompatibility and is used in a wide range of indications, such as frameworks, implants, and abutments. In addition, it's very good long-term stability and reliability was proven in a 10-year clinical study. These excellent material properties and the transformation behavior are explained by the yttrium oxide stabilization of ZrO2.

研究工具

Experimental: BioHPP PEEK single posterior crowns
BioHPP PEEK copings veneered with composite resin
Active Comparator: zirconia-based single posterior crowns
yttria stabilized tetragonal zirconia used as copings to be veneered with porcelain

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

November 1, 2019

预计主要完成日期

October 1, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. From 18-50 years old, be able to read and sign the informed consent document. 2. Have no active periodontal or pulpal diseases, have teeth with good restorations 3. Psychologically and physically able to withstand conventional dental procedures 4. Patients with teeth problems indicated for single posterior crowns: 1. Badly decayed teeth 2. Teeth restored with large filling restorations 3. Endodontically treated teeth 4. Malformed teeth 5. Malposed teeth (Tilted, over-erupted, rotated, etc.) 6. Spacing between posterior teeth 5. Able to return for follow-up examinations and evaluation Exclusion Criteria: 1. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposing dentition in the area of interest 8. Failed endodotically treated teeth; short or overextended, narrow, missed canal, ledge or perforated teeth (even if no clear symptoms for failure)

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：50 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Aya Ezzat Mohamed Ali El-shimy，Cairo University

研究赞助商 ^ICMJE

Cairo University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Cairo University

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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