Accuracy of AI-Assisted Static Surgical Guides in Delayed Dental Implant Placement in The Maxillary Esthetic Zone: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Higher accuracy of AI assisted surgical guide
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Missing teeth in esthetic zone of maxilla. 2-Both genders (male and female). 3- Adult ages (from 21 years to 60 years).
排除标准
- •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).
结局指标
主要结局
Higher accuracy of AI assisted surgical guide
时间窗: 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
次要结局
- Successful Osseointegration(6 months postoperative follow up)
研究者
Alshaimaa saeed
Resident doctor
Suez Canal University