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Accuracy of Computer Guided Implant Placement in Edentulous or Partially Edentulous Patients Using Artificial Intelligence Technology vs Conventional Method A Randomized Clinical Trial

31. mai 2026 oppdatert av: Eslam Nashaat Saied Ahmed Mohamed, Future University in Egypt
This study at Future University in Egypt aims to compare two modern methods of placing dental implants: one using artificial intelligence (AI)-assisted computer planning and the other using conventional computer-guided planning. Participants who have missing teeth will receive dental implants using a customized 3D-printed surgical guide designed from CBCT scans. The study will evaluate how accurately the implants are placed and whether AI technology can improve precision and treatment planning. Participants will undergo examination, implant surgery, healing, and follow-up visits, including scans before and after treatment. Like any implant procedure, there may be risks such as swelling, infection, or implant failure, but patients will be closely monitored throughout the study.

Studieoversikt

Detaljert beskrivelse

This clinical study is being conducted at Future University in Egypt as part of a doctoral research project in Oral and Maxillofacial Surgery. The purpose of the study is to evaluate and compare the accuracy of dental implant placement using two different computer-guided techniques: an Artificial Intelligence (AI)-assisted digital planning method and a conventional computer-guided planning method.

Dental implants are commonly used to replace missing teeth and restore oral function and appearance. Accurate implant placement is very important to avoid complications and to ensure long-term success. Modern implant dentistry increasingly depends on digital planning and 3D surgical guides to improve safety and precision during surgery.

In this study, patients who are partially or completely missing teeth will undergo clinical examination and CBCT (Cone Beam Computed Tomography) imaging before treatment. Participants will then be randomly assigned into one of two groups. The first group will use AI-assisted planning software that automatically helps identify important anatomical structures, detects missing teeth, and assists in planning the ideal implant position. The second group will use a conventional digital planning method performed manually by the clinician using standard software.

For both groups, a customized surgical guide will be designed and fabricated using 3D-printing technology. During surgery, the guide will help the surgeon place the dental implants in the planned position with high precision. After implant placement, patients will receive routine postoperative care and follow-up. A healing period of approximately three months will be allowed before placement of the final crown or bridge restoration.

To evaluate the accuracy of the procedure, postoperative CBCT scans will be compared with the original virtual treatment plan. The study will measure any differences between the planned and actual implant positions, including implant depth, angle, and overall positioning.

The study aims to determine whether AI-assisted implant planning can improve the precision, efficiency, and predictability of guided implant surgery compared with conventional digital planning methods. The results may contribute to improving future dental implant treatment and digital surgical workflows.

Participation in this study is voluntary, and all patient information will remain confidential. Possible risks are similar to those associated with standard dental implant surgery and may include pain, swelling, bleeding, infection, temporary numbness, or implant failure. Patients will be closely monitored throughout treatment, and any complications will be managed by the research team.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • New Cairo
      • Cairo, New Cairo, Egypt, 11835
        • Future University in Egypt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Patients who are partially or completely edentulous.
  2. Patient aged 21 to 60 years old
  3. A willingness to cooperate with study protocol and follow-up program

Exclusion Criteria:

  1. Medical contraindications to dental treatment.
  2. Uncontrolled periodontal disease that interfere with healing.
  3. Cancer Patient (under radiation / chemotherapy).
  4. Present of any acute local infection.
  5. Uncontrolled diabetic patient.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group A: AI-assisted computer-guided implant planning
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine. The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent. The stent is then exported to STL file and printed. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide.
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine. The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent. The stent is then exported to STL file and printed. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide CBCT will be taken post-operatively for the patient with the implants in place. The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
Aktiv komparator: Group B: Conventional computer-guided implant planning
The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide. This procedure will be performed on both completely edentulous and partially edentulous patients.

The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide. This procedure will be performed on both completely edentulous and partially edentulous patients.

CBCT will be taken post-operatively for the patient with the implants in place. The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
implant angular deviation and implant depth
Tidsramme: From enrollment to the end of treatment at 12 weeks
CBCT will be taken post-operatively for the patient with the implants in place. The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
From enrollment to the end of treatment at 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2024

Primær fullføring (Faktiske)

10. august 2025

Studiet fullført (Faktiske)

25. februar 2026

Datoer for studieregistrering

Først innsendt

31. mai 2026

Først innsendt som oppfylte QC-kriteriene

31. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2026

Sist bekreftet

1. desember 2023

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • FUE.REC(42)/12-2023

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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