Accuracy of AI Assisted Surgical Guide (AISG)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorSuez Canal University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implant placement using Conventional static surgical guide

    Procedure/Surgery

    Conventional digitally planned surgical guide used for guided implant placement.

  • Implant placement using AI assisted surgical guide

    Procedure/Surgery

    AI assisted surgical guide for guided placement of dental implants

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: conventional static surgical guideExperimental treatment 1 intervention
Group B: AI assisted static surgical guideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Higher accuracy of AI assisted surgical guide

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

Time frame
Within 24 hours after implant placement

Secondary outcomes

1

Successful Osseointegration

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.

Time frame
6 months postoperative follow up

Other outcomes

Sponsors and contacts

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