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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 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
implant angular deviation and implant depth
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2024

Achèvement primaire (Réel)

10 août 2025

Achèvement de l'étude (Réel)

25 février 2026

Dates d'inscription aux études

Première soumission

31 mai 2026

Première soumission répondant aux critères de contrôle qualité

31 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mai 2026

Dernière vérification

1 décembre 2023

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • FUE.REC(42)/12-2023

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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