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临床试验/NCT07393269
NCT07393269已完成不适用

Accuracy of Implant Impression Techniques Using Scannable Healing Abutments Versus Conventional Methods. A Controlled Clinical Trial

Sherif Aly Sadek1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年7月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Three-dimensional implant positional accuracy (RMS deviation)

研究概览

简要总结

This prospective controlled clinical trial evaluates the three-dimensional positional accuracy of implant-level impressions obtained using scannable healing abutments compared with conventional open-tray and closed-tray impression techniques in partially edentulous patients with unilateral free-end saddle situations.

详细描述

Accurate transfer of implant position is critical for achieving passive fit of implant-supported prostheses. This study compares the trueness of implant impressions obtained using a digital workflow based on scannable healing abutments with conventional open-tray and closed-tray impression techniques. Twenty-two partially edentulous patients with unilateral distal extension ridges will undergo all three impression techniques. Three-dimensional deviations will be quantified using best-fit superimposition and root mean square analysis, with the open-tray technique serving as the reference standard.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Partially edentulous patients with unilateral free-end saddle (Kennedy Class II)
  • Adequate bone for two implants
  • Good systemic health
  • Ability to provide informed consent

排除标准

  • Active periodontal disease
  • Poor oral hygiene
  • Parafunctional habits
  • Temporomandibular disorders
  • Heavy smoking (>10 cigarettes/day)

研究组 & 干预措施

Scannable Healing Abutment Digital Impression

Experimental

Intraoral digital impression using scannable healing abutments and an intraoral scanner.

干预措施: Digital implant impression using scannable healing abutments (Procedure)

Open-Tray Conventional Impression

Active Comparator

Conventional splinted open-tray implant impression using polyvinyl siloxane.

干预措施: Open-tray implant impression (Procedure)

Closed-Tray Conventional Impression

Active Comparator

Conventional closed-tray implant impression using polyvinyl siloxane.

干预措施: Closed-tray implant impression (Procedure)

结局指标

主要结局

Three-dimensional implant positional accuracy (RMS deviation)

时间窗: Periprocedural (single assessment, 1 week after second-stage implant surgery)

Root mean square (RMS) deviation (µm) between test impressions and the open-tray reference model using 3D metrology software.

次要结局

  • Comparison of implant positional accuracy between impression techniques(Periprocedural (single assessment, 1 week after second-stage implant surgery))

研究者

发起方
Sherif Aly Sadek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherif Aly Sadek

Associate Professor

Cairo University

研究点 (1)

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