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Accuracy of AI Assisted Surgical Guide (AISG) (AISG)

2026年7月13日 更新者:Alshaimaa saeed、Suez Canal University

Accuracy of AI-Assisted Static Surgical Guides in Delayed Dental Implant Placement in The Maxillary Esthetic Zone: A Randomized Controlled Trial

The purpose of this study is to evaluate and compare the accuracy of conventional static surgical guide and AI-assisted static surgical guide in implant placement in the esthetic zone of partially edentulous maxilla , This study will be carried out on patients seeking implant placement in partially edentulous esthetic zone of maxilla, selected from those who were referred to outpatient clinic of the department of oral and maxillofacial surgery, Faculty of Dentistry, Suez Canal University. The main research question is assessing what the difference is upon using AI-assisted surgical guide in terms of the accuracy of implant angular and linear deviation, and implant depth. The expected outcome is that The use of AI-assisted surgical guide in implant placement may provide higher accuracy and less deviation than the conventional static surgical guide. This clinical study will be conducted on 20 surgical guides for placement of 20 implants, divided into 2 groups: Group 1: 10 conventional computer-guided static guides for placement of 10 implants (as control group) Group 2: 10 AI-assisted static surgical guides for placement of 10 implants (as study group) The selected patients will get a pre operative CBCT scan and an intraoral scan then the guide design and generation will be performed using conventional software or AI integrated software according to randomization chart generated by "www.randomizer.org", and after the surgery of implant placement through the prefabricated guides the patients will get an immediate post operative CBCT scan.

研究概览

详细说明

Wide research has been conducted to enhance the accuracy of implant placement within the bone while adopting more conservative techniques to improve overall success rates. The digital workflow for computer-aided implant surgery includes a range of steps leading to generation of a prosthetically driven, 3-dimensional virtual plan, and generation of static surgical guide. The use of AI integrated software decreases those steps drastically and seems to be a time saver. This study aims to evaluate and compare the accuracy of conventional static surgical guide and AI-assisted static surgical guide in implant placement in the esthetic zone of partially edentulous maxilla. This clinical study will be conducted on 20 surgical guides, divided equally and randomly via (www.randomizer.org) into 2 groups: Group 1: 10 implants will be placed using 10 conventional surgical guides which are made using traditional manual planning & designing (control group). Group 2: 10 implants will be placed using 10 AI-assisted surgical guides crafted with the help of machine learning-based planning software (study group). AI integrated software performs thorough analysis of the patient's anatomy & a personalized and precise approach of implant placement. By automating the planning process, AI-assisted guides help reduce human error, planning time and provide precise, data-driven recommendations for implant placement position.

Objectives of this study is

Radiographic assessment through:

  • pre-operative CBCT & immediate postoperative CBCT to measure and compare angular and linear deviation, and implant depth between planned and actual implant positions in both groups.
  • 6 months post operative CBCT for measuring marginal bone level

    • peri implant bone density.

Clinical assessment through:

• Measuring implant stability quotient (ISQ) by Osstell ISQ Scale immediately and 6 months post operative.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Ismailia、埃及
        • Faculty of Dentistry, Suez Canal University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 1- Missing teeth in esthetic zone of maxilla. 2-Both genders (male and female). 3- Adult ages (from 21 years to 60 years).

Exclusion Criteria:

  • Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia). 2- Patient with oral habit as bruxism, heavy smoking. 3- Patient with bad oral hygiene. 4- Patient with severe gingival diseases. 5- Patient with severe periodontal diseases (with severe vertical or horizontal bone loss).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:conventional static surgical guide
Conventional digitally planned surgical guide used for guided implant placement.
有源比较器:AI assisted static surgical guide
AI assisted surgical guide for guided placement of dental implants

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Higher accuracy of AI assisted surgical guide
大体时间:Within 24 hours after implant placement

The deviation between the planned and the actual implant positions will be measured in three dimensions:

1) 2) Angular deviation calculated in degrees. Linear deviation at implant platform and implant apex in millimeters. 3) Implant depth in millimeters The less the deviation, the higher the accuracy

Within 24 hours after implant placement

次要结果测量

结果测量
措施说明
大体时间
Successful Osseointegration
大体时间:6 months postoperative follow up
Implant stability will be measured using an Osstell device (Implant Stability Quotient - ISQ). 6 months Post-operative CBCT for measuring marginal bone level & peri implant bone density.
6 months postoperative follow up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月14日

初级完成 (估计的)

2027年5月14日

研究完成 (估计的)

2027年7月14日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

There is no plan to share individual participant data due to institutional policies and participant confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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