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临床试验/NCT02461823
NCT02461823Unknown不适用

The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health

Rambam Health Care Campus0 个研究点目标入组 20 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
PgE2 ( Prostaglandin E2)

研究概览

简要总结

Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.

详细描述

Porcelain fused to metal (PFM) has been used in dentistry for the last five decades.

Zirconia (zirconium oxide, ZrO2) is the white crystalline powder oxide of the naturally occurring metal zirconium. Research of the medical utilization of zirconia dates back to the late 1960s. However, its utilization in dentistry did not start until the 1990s, when zirconia began to be used as a form of endodontic posts and implant abutments. The current literature contains studies that investigated the influence of zirconia implants and abutments on periodontal tissue, but to the investigators' knowledge, no work has been yet published which compares the influences of crown types on hard and soft tissues.

This prospective study will be conducted in the Department of Periodontology and in the Department of Maxillofacial Rehabilitation at Rambam Health Care Campus.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient age 18 - 85 years old
  • •In need for one or more fixed partial prosthetic crown or bridge

排除标准

  • •Active periodontal disease
  • •history of compromising systemic disease
  • •Allergy to materials used in the study
  • •current drug abuse
  • •Pregnant or intend to become pregnant
  • •severe salivary gland dysfunction
  • •Severe medical complications ( organ transplants, cancer, immunocompromised, or undergoing long-term antibiotic or steroid therapy )

研究组 & 干预措施

Z Crown

Experimental

A Zirconia crown will be provided to patients.

干预措施: Zirconia crown (Device)

PFM Crown

Active Comparator

A Porcelain metal crown will provided to patients.

干预措施: Porcelain metal crown (Device)

结局指标

主要结局

PgE2 ( Prostaglandin E2)

时间窗: 4 months

Gingival cervicular fluid samples will be attempt be planning Periotrom paper in the mesial and distal aspect of the experimental teeth. This samples will be assayed for PgE2 ( Prostaglandin E2) using Elyza kit. The concentration of PGE2 in gingival crevicular fluid will be examined around each tooth receiving a crown.

次要结局

  • bone level(4 months)
  • Clinical attachment level(4 months)
  • Pocket depth(4 months)
  • PIaque index(4 months)
  • GIingival index(4 months)

研究者

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

Ilan Hirsh MD

Senior staff Member Department of Periodontology, Rambam Health Care Campus, Haifa

Rambam Health Care Campus

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