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

13. juli 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Ismailia, Egypten
        • Faculty of Dentistry, Suez Canal University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: conventional static surgical guide
Conventional digitally planned surgical guide used for guided implant placement.
Aktiv komparator: AI assisted static surgical guide
AI assisted surgical guide for guided placement of dental implants

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Higher accuracy of AI assisted surgical guide
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful Osseointegration
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

14. juli 2026

Primær færdiggørelse (Anslået)

14. maj 2027

Studieafslutning (Anslået)

14. juli 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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