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临床试验/NCT04023357
NCT04023357Unknown不适用

Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.

Cairo University0 个研究点目标入组 22 人开始时间: 2019年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
主要终点
evaluation of marginal gap

研究概览

简要总结

Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.

.but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects are required to be:
  • From 18-60 years old, and able to read and sign the informed consent document.
  • Physically and psychologically able to tolerate conventional restorative procedures
  • Have no active periodontal or pulpal diseases.
  • Willing to return for follow-up examinations and evaluation

排除标准

  • Patients in the growth stage with partially erupted teeth
  • Patient with fractured teeth of more than 50% enamel loss
  • Patients with poor oral hygiene and motivation
  • Pregnant women
  • Psychiatric problems or unrealistic expectations
  • Lack of opposite occluding dentition in the area intended for restoration

研究组 & 干预措施

PEEK

Experimental

PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics,1 Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.

Yet clinical studies are needed to evaluate their clinical performance.

干预措施: PEEK (Other)

Emax

Active Comparator

lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for Endocrowns

干预措施: Emax (Other)

结局指标

主要结局

evaluation of marginal gap

时间窗: through study completion, an average of 1 year

Marginal gap of the restorations assessed by Silicon replica technique using digital microscope

次要结局

  • Clinical evaluation of marginal adaptation(1 Year)
  • Clinical evaluation of fracture resistance(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed mohamed osman Youssef

Internal resident faculty of oral & dental medicine Cairo University

Cairo University

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