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临床试验/NCT07723404
NCT07723404招募中不适用

Accuracy of Complete-Arch Implant Scans Obtained Using Non-Calibrated Splinting Bodies and a Mobile Phone-Based Photogrammetry System (T-Marker): A Randomized Crossover Clinical Trial

Menoufia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Trueness of Complete-Arch Implant Position Recording

研究概览

简要总结

This randomized crossover clinical trial aims to compare the accuracy and scanning efficiency of two digital techniques for recording implant positions in completely edentulous patients receiving implant-supported full-arch prostheses. Each participant will undergo digital impressions using both a non-calibrated splinting scan body system (IoConnect) with an intraoral scanner and a mobile phone-based photogrammetry system (T-Marker). The order of the two scanning methods will be randomized.

The primary outcome is the accuracy (trueness) of implant position recording, assessed by comparing each digital impression with a verified reference model. Secondary outcomes include the time required to complete each digital impression. The findings of this study may help determine whether these digital workflows provide accurate and efficient alternatives for complete-arch implant impressions, thereby supporting clinical decision-making in implant prosthodontics.

详细描述

Detailed Description

Accurate recording of implant positions is essential for the fabrication of passively fitting implant-supported full-arch prostheses. Although intraoral scanners have demonstrated acceptable accuracy for single implants and short-span restorations, complete-arch implant scanning remains challenging because of the absence of stable anatomical landmarks, long interimplant distances, and cumulative image stitching errors. To overcome these limitations, several digital impression techniques have been developed, including splinted implant scan body systems and photogrammetry-based workflows.

Recently, non-calibrated splinting scan body systems have been introduced to improve the stability of implant scan bodies during intraoral scanning without requiring scanner-specific calibration. In parallel, mobile phone-based photogrammetry systems have emerged as simplified and more accessible alternatives for capturing implant positions. However, clinical evidence directly comparing these technologies is limited.

This prospective randomized crossover clinical trial will compare the accuracy and scanning efficiency of a non-calibrated splinting scan body workflow (IoConnect) with a mobile phone-based photogrammetry system (T-Marker) for complete-arch implant impressions. Twenty-four completely edentulous patients rehabilitated with four implant-supported multiunit abutments will undergo digital impressions using both techniques. The order of the scanning procedures will be randomized using a computer-generated randomization sequence, allowing each participant to serve as their own control.

A verified conventional splinted impression and master cast will be fabricated for each participant and digitized with a high-accuracy laboratory scanner to generate the reference dataset. Digital impressions obtained with both workflows will be compared with the reference model using three-dimensional metrology software. Trueness will be evaluated by measuring linear and angular deviations of implant positions after standardized replacement of the scan bodies with their corresponding CAD library files and construction of an identical virtual implant-supported bar for all datasets.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Completely edentulous maxilla rehabilitated with four well-integrated implants connected to multiunit abutments.
  • Patients presenting with a screw-retained interim implant-supported prosthesis or requiring a definitive implant-supported prosthesis.
  • Adequate implant osseointegration with no clinical signs of implant failure.
  • Ability to understand the study procedures and provide written informed consent.

排除标准

  • Fewer than four implants supporting the maxillary prosthesis.
  • Implants located outside the maxillary arch.
  • Failed implants or implants exhibiting mobility.
  • Active peri-implant infection or suppuration.
  • Inability to tolerate intraoral scanning or comply with study procedures.
  • Refusal or inability to provide written informed consent.

研究组 & 干预措施

Experimental: IoConnect → T-Marker

Experimental

Participants first undergo complete-arch digital implant impressions using the non-calibrated splinting workflow (IoConnect), followed by the mobile phone-based photogrammetry workflow (T-Marker).

干预措施: Non-Calibrated Splinting Scan Body System (IoConnect) (Device)

Experimental: IoConnect → T-Marker

Experimental

Participants first undergo complete-arch digital implant impressions using the non-calibrated splinting workflow (IoConnect), followed by the mobile phone-based photogrammetry workflow (T-Marker).

干预措施: Mobile Phone-Based Photogrammetry System (T-Marker) (Device)

Experimental: T-Marker → IoConnect

Experimental

Participants first undergo complete-arch digital implant impressions using the mobile phone-based photogrammetry workflow (T-Marker), followed by the non-calibrated splinting workflow (IoConnect).

干预措施: Non-Calibrated Splinting Scan Body System (IoConnect) (Device)

Experimental: T-Marker → IoConnect

Experimental

Participants first undergo complete-arch digital implant impressions using the mobile phone-based photogrammetry workflow (T-Marker), followed by the non-calibrated splinting workflow (IoConnect).

干预措施: Mobile Phone-Based Photogrammetry System (T-Marker) (Device)

结局指标

主要结局

Trueness of Complete-Arch Implant Position Recording

时间窗: Immediately after completion of each digital impression (during the 1 day study visit).

Trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset generated from a conventional splinted impression. Three-dimensional analysis will be performed using reverse-engineering software to calculate the linear (µm) and angular (degrees) deviations of implant positions. Lower deviation values indicate greater trueness.

Angular Deviation of Complete-Arch Implant Position Recording

时间窗: Immediately after completion of each digital impression (during the 1 day study visit).

Angular trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset. Three-dimensional analysis will be performed using reverse-engineering software to calculate the angular deviation (degrees) of implant axes. Lower values indicate greater trueness.

次要结局

  • Effective Chairside Scanning Time(Immediately after completion of each digital impression (during the 1 day study visit).)

研究者

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

Mohammed El-Sawy

Lecturer of Prosthodontics

Menoufia University

研究点 (1)

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