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临床试验/NCT02861729
NCT02861729已完成不适用

Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Survival rate

研究概览

简要总结

The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.

详细描述

This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants:
  • Good oral hygiene, papillary bleeding index (PBI) < 35%.
  • Positive patient acceptance to participate in the trial.
  • Carious class II or MOD lesions
  • Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • Normal occlusion
  • Single tooth restoration (no edentulous space that requires fixed prosthesis)

排除标准

  • Participants
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Bad oral hygiene
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or temporomandibular disorders.
  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Tooth hypersensitivity.
  • Rampant caries.
  • Non-vital or endodontically treated teeth.
  • Sever periodontal affection.
  • Tooth mobility

研究组 & 干预措施

Suprinity

Experimental

Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate PCRs

干预措施: Vita Suprinity (Other)

e.max

Active Comparator

IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs

干预措施: IPS e.max (Other)

结局指标

主要结局

Survival rate

时间窗: 12 month

Absolute failure is defined by clinical unacceptable fracture and crack development which required a replacement of the entire restoration, and/or secondary caries as well as endodontic complications

次要结局

  • Restorations with surface roughness as assessed tactilely by US public health service criteria(12 month)
  • Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria(12 month)
  • Restorations with Marginal gap as assessed visually by US public health service criteria(12 month)
  • Restorations with Marginal discoloration as assessed visually by US public health service criteria(12 month)
  • Restorations developed secondary caries as assessed visually by US public health service criteria(12 month)

研究者

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

Hanaa Sayed abdo Hassan Nassar

PHD student

Cairo University

研究点 (1)

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