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临床试验/NCT05105113
NCT05105113招募中不适用

Evaluation of Survival and Success Rates of Zirzonia Dental Implants

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Evaluate Tav- implant survival.

研究概览

简要总结

Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)

详细描述

In the last three decades the use of dental implants to support oral rehabilitation has become a common treatment in dentistry and orthopedics.

The implants are made of titanium alloy and have shown high safety and effectiveness.

However, the gray color of the implant may be reflected through the gums and impair aesthetics in the areas of the front of the mouth.

Against this background, in recent years, implant companies have developed zirconia implants, which are white in color.

Studies have shown an aesthetic advantage for zirconia implants and zirconia structures compared to titanium when placed in an aesthetic area in patients with thin gums.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject must have voluntarily signed the informed consent form.
  • Male or female patient aged ≥18 Years old.
  • Replacing a missing tooth by use of implant supported restoration in implantation sites that do not require extensive augmentation procedure.
  • Good primary implant stability at implant placement (35N and more).
  • Compliance with study schedules and arrival at study visits.

排除标准

  • Pregnant or lactating women.
  • Imbalance diabetes.
  • Head and neck rediation therapy.
  • Active Periodontal disease and caries.
  • Patient in need of tooth extraction and immediat implantation.

结局指标

主要结局

Evaluate Tav- implant survival.

时间窗: 12 months

Implant survival means that implants are still in the mouth. at the time of examination, regardless of the state of the prosthesis or patient satisfaction.

次要结局

  • Evaluate Tav-Implant probing depth (IPD)(12 months.)
  • Evaluate Tav-implant Plaque index (PI) changes.(4 weeks, 12 weeks, 12 months)
  • Evaluate Tav-implant Pink Esthetic Score (PES) changes.(4 weeks, 12 weeks, 12 months.)
  • Evaluate Tav-implant Bleeding on probe (BOP)(12 months.)
  • Evaluate Tav-implant Gingival index (GI) changes.(4 weeks, 12 weeks, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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