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临床试验/NCT03333889
NCT03333889Unknown不适用

Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年1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
36
试验地点
1
主要终点
patient satisfaction

研究概览

简要总结

P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?

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)

盲法说明

double blind :outcome asessor,participant

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

  • Patients above 18 years old.
  • Patients able to read and sign the informed consent document.
  • Medically free patients or with controlled systemic disease.
  • Patients with good bone quality and quantity evaluated using C.B.C.T.
  • Patients willing to return for follow-up examinations and evaluation.
  • Patients having single missing recently extracted premolar tooth.

排除标准

  • Young patients in growth stage.
  • Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
  • Pregnant women to avoid any complication that may occur in dental office.
  • Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
  • Psychiatric problems or unrealistic expectations.
  • Multiple adjacent missing teeth.
  • Patients with bad oral hygiene. -

研究组 & 干预措施

E-max hybrid crown

Active Comparator

E-max hybrid crown Lithium Disilicate based ceramic which is characterized by high strength and optimum esthetics and considered a gold standard in anterior restorations

干预措施: emax hybrid crown (Other)

Vita Enamic hybrid crown

Experimental

Vita Enamic hybrid crown polymer infilltrated ceramic network(hybrid ceramic) characterized by low modulus of elasticity that acts as cushion on implants.

干预措施: Vita Enamic hybrid crown (Other)

结局指标

主要结局

patient satisfaction

时间窗: 12 months

using visual analogue scale (o-unsatisfied up to max 10 satisfied)

次要结局

  • crestal bone loss(12 months)

研究者

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

Inas Adel Mahmoud

assistant lecturer,fixed prosthodontic department, faculty of oral and dental medicine

Cairo University

研究点 (1)

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