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

NCT07627841 | Completed DMC

• 1 other identifier: FUE.REC(42)/12-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partially Edentulous Maxilla, Mandible; Edentulous Alveolar Ridge

Keywords

computer guided implant placement; implant; implant accuracy; AI

Outcome Measures

Primary Outcomes (1)

• implant angular deviation and implant depth

  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

Study Arms (2)

Group A: AI-assisted computer-guided implant planning

ACTIVE COMPARATOR

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.

Device: Group A: AI-assisted computer-guided implant planning

Group B: Conventional computer-guided implant planning

ACTIVE COMPARATOR

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.

Device: Group B: Conventional computer-guided implant planning

Interventions

Group A: AI-assisted computer-guided implant planning DEVICE

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.

Group A: AI-assisted computer-guided implant planning

Group B: Conventional computer-guided implant planning DEVICE

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.

Group B: Conventional computer-guided implant planning

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: January 1, 2024
• Primary Completion: August 10, 2025
• Study Completion: February 25, 2026
• Last Updated: June 4, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)