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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge; Partially Edentulous Maxilla, Mandible
• Intervention / Treatment: Device: Group A: AI-assisted computer-guided implant planning; Device: Group B: Conventional computer-guided implant planning

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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 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.
Active Comparator: 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.	Device: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): August 10, 2025
• Study Completion (Actual): February 25, 2026

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: AI; implant; computer guided implant placement; implant accuracy
• Other Study ID Numbers: FUE.REC(42)/12-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No