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临床试验/NCT05011604
NCT05011604已完成不适用

Full-Digital Workflow in Single-Tooth Implant Rehabilitation

Francesco Gianfreda2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年1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
19
试验地点
2
主要终点
Predictability in cases of intercalated edentulism

研究概览

简要总结

The digital workflow in dental implantology has been used for planning the cases with the intraoral scanners and computer tomography, together helping clinicians to be more accurate and precise. Today, thanks to digital technology clinicians can plan from surgical to the final prosthesis using 3D models and cad-cam machines. The aim of this research is to validate the full digital workflow for the single-tooth implant rehabilitation. A total of 19 patients (22 implants) were included in the present study with mean follow-up time of 2 years. A full-digital workflow was performed on each patient through the design and printing of a surgical guide, the taking of the impression with an intraoral scanner and the CAD-CAM design of the crowns.

详细描述

Study design The present study was a retrospective case series conducted in one clinical center in accordance with the Good Clinical Practice Guidelines (GCPs) following the recommendations of the World Medical Association Declaration of Helsinki-ethical principles for medical research involving human subjects as revised in Fortaleza (2013).

All patients were informed about the benefits and the possible risks of a fully digital workflow and its alternatives finally a signed written consent was obtained. Subject population

The current retrospective study was performed in a private clinic in Rome, Italy, where all patients treated by the same operator between January 2017 and June 2020 were consecutively enrolled:

  • Patients older than 18 years
  • Patients in good health (Asa 1 or Asa 2)
  • Patients with healthy periodontium (probing pocket depth ≤ 4 mm, no bleeding on probing)
  • Patients not requiring bone augmentation procedures Patients requiring a single implant supported reconstructions were included in the present study.

Surgical and prosthetic workflow For all patients included in the study, a digital impression was taken using an intraoral scanner (CS3600, Carestream Dental, Atlanta, Ga). During the same day, a CBCT (CS9000 3D, Carestream Dental, Atlanta, Ga) exam was performed on the mandibular or maxillary jaw with the missing tooth. The stl. and the dicom. files were then superimposed to allow the surgical planning (RealGuide, 3Diemme, Cantù, Italy).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years
  • Patients in good health (Asa 1 or Asa 2)
  • Patients with healthy periodontium (probing pocket depth ≤ 4 mm, no bleeding on probing)

排除标准

  • Patients requiring bone augmentation procedures

结局指标

主要结局

Predictability in cases of intercalated edentulism

时间窗: 1 year

Implant success

次要结局

未报告次要终点

研究者

发起方
Francesco Gianfreda
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francesco Gianfreda

PhD Student

University of Rome Tor Vergata

研究点 (2)

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