Accuracy of AI Assisted Surgical Guide (AISG)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Implant placement using Conventional static surgical guide
  Conventional digitally planned surgical guide used for guided implant placement.
• Процедура Implant placement using AI assisted surgical guide
  AI assisted surgical guide for guided placement of dental implants

Первичные конечные точки

• Higher accuracy of AI assisted surgical guide [Срок оценки: Within 24 hours after implant placement]

Вторичные конечные точки (1)

• Successful Osseointegration [Срок оценки: 6 months postoperative follow up]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of dentistry, Suez Canal University — Ismailia

Идентификаторы

NCT: NCT07711613 · 1148

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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