Accuracy of AI Assisted Surgical Guide (AISG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implant placement using Conventional static surgical guide, Implant placement using AI assisted surgical guide.
- Who it may be relevant to
- Registry conditions: Accuracy of AI App, Accuracy of AI Assisted Surgical Guides. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accuracy of AI-Assisted Static Surgical Guides in Delayed Dental Implant Placement in The Maxillary Esthetic Zone: A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure Implant placement using Conventional static surgical guide
Conventional digitally planned surgical guide used for guided implant placement. - Procedure Implant placement using AI assisted surgical guide
AI assisted surgical guide for guided placement of dental implants
Primary outcome measures
- Higher accuracy of AI assisted surgical guide [Time frame: Within 24 hours after implant placement]
Secondary outcome measures (1)
- Successful Osseointegration [Time frame: 6 months postoperative follow up]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry, Suez Canal University — Ismailia
Identifiers
NCT: NCT07711613 · 1148