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临床试验/NCT07259265
NCT07259265已完成不适用

Longterm Outcomes of Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns: a Randomized, Controlled, Clinical Trial

Dr. med. dent. Malin Strasding1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年3月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Restoration survival

研究概览

简要总结

The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. The onlays are made either out of a lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or out of a lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann). The crowns are made either out of lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent).

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Subjects with the need for a fixed reconstruction in premolar and molar region with indication for either crown or onlay.
  • min. 18 years of age and ≤ 80 years
  • Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
  • Capable of providing written informed consent
  • Absence of any active periodontal and pulpal disease

排除标准

  • Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids e.g. history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.
  • Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, Hepatitis
  • History of neoplastic disease requiring the use of radiation or chemotherapy
  • Inability to perform adequate oral hygiene
  • Significant reduced saliva flow rate
  • Unable or unwilling to cooperate for the trial period
  • Allergy to any components of the reconstruction materials and cements
  • Alcohol or drug abuse
  • Pregnant or lactating women
  • Specific criteria:
  • Root caries / root canal caries
  • Extreme short dental arch (eSDA)
  • Severe bruxism or clenching habits

结局指标

主要结局

Restoration survival

时间窗: 5 years

Survival of the inserted restorations

次要结局

  • Fractures of the restorations.(5 years)
  • Tooth vitality(5 years)
  • Biological outcome - presence of secondary caries(5 years)
  • Biological outcome - tooth fractures(5 years)
  • Biological outcome - pocket probing depth(5 years)
  • Biological outcome - Bleeding on Probing(5 years)
  • Biological outcome - Plaque index(5 years)

研究者

发起方
Dr. med. dent. Malin Strasding
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. dent. Malin Strasding

PD Dr med dent

University of Geneva, Switzerland

研究点 (1)

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