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临床试验/NCT04061694
NCT04061694已完成不适用

Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.

Folktandvården Skåne AB1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
MBL

研究概览

简要总结

To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age who had signed an informed consent
  • in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.

排除标准

  • general contraindications for oral surgery
  • patients with inadequate oral hygiene
  • need for bone grafting or ridge augmentation.

结局指标

主要结局

MBL

时间窗: 12 months

Marginal bone loss MBL, measured in mm from implant abutment junction.

Pink Esthetic Score

时间窗: 12 months

Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.

White Esthetic Score

时间窗: 12 months

White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.

Number of Participants With Implant Survival

时间窗: 12 months

Survival of dental implants. 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

Oral Health Impact Profile - 14

时间窗: 12 months

Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.

次要结局

未报告次要终点

研究者

发起方
Folktandvården Skåne AB
申办方类型
Other
责任方
Principal Investigator
主要研究者

Björn Gjelvold

Specialist in Oral Prosthodontics

Folktandvården Skåne AB

研究点 (1)

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