Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Guided Implant Placement (Implant)

Assessment of the Accuracy of Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Computer Guided Implant Placement: A Randomized Controlled Clinical Trial.

The AI assisted CAD/CAM workflow will be adopted for the treatment planning and guide design generation with the aim of comparing precision of implant placement with conventional digital workflow.

Study Overview

• Status: Recruiting
• Conditions: Partially Edentulous Mandible
• Intervention / Treatment: Procedure: Conventional computer guided implant placement; Procedure: AI assisted implant placement

Detailed Description

The study will be conducted in Oral and Maxillofacial Department, Faculty of Oral and Dental Medicine, Cairo University.After patient's selection, the CBCTs will be captured for the edentulous area along with a full arch PVS impression for the upper and lower arches. The patients will then be randomly allocated into two groups. Group I, AI assisted group, the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed. For Group II, Static CAIS group, the virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. The guides will then be disinfected to be ready for the surgical procedure. All patients will be administered 400 mg Ibuprofen 1 hour prior to surgery and will be instructed to rinse with a 0.12% Chlorhexidine solution for 60 s. After administration of local anesthesia,implant placement will be performed according to the allocated treatment protocol by one experienced surgeon. The following process will be the same for both guided techniques. The fit and stability of the 3D surgical guide will be verified prior to the surgery through tactile inspection and confirming the fit through the inspection window areas of the guide on top of the teeth. Implant bed preparations and implant insertions will be done through the 3D surgical guide in accordance with the manufacturer's fully guided surgical protocol. The drilling sequence will be followed as needed for each case. The implant will be placed via a fully guided implant placement regimen and a healing abutment will be placed for transmucosal healing. Wound suturing will be performed as needed and all the patients will receive postoperative instructions and will be appointed for a follow up and suture removal visit one week postoperatively. All patients will have an immediate postoperative CBCT.

The postoperative medications list will include systemic antibiotics (1 g of amoxicillin, twice a day) and an analgesic (500 mg of mefenamic acid, three times a day) for 5 days. For patients who were allergic to penicillin, 300 mg of clindamycin will be prescribed three times a day.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sandra Moussa El Tarzi, BDS; Phone Number: +201226665141; Email: sandra.eltarzi@dentistry.cu.edu.eg
• Study Contact Backup: Name: Nehal IA Shobair, PhD; Phone Number: 00201063666985; Email: nehal.shobair@miuegypt.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt
      • Recruiting
      • Faculty of Dentistry - Cairo University
      • Contact: Nehal I Shobair, Teacher; Phone Number: 00201063666985; Email: nehal.shobair@miuegypt.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Kennedy class III partially edentulous patient with or without modifications.
• Patients who need single implant posterior site delayed implant placement.
• Patients above 18 and below 60 years of age.
• Natural healthy neighboring teeth without need of new restorations.

Exclusion Criteria:

• Patients with D4 bone density.
• Patients with known systemic or local diseases or treatments which can affect normal tissue healing.
• Patients who are heavy smokers.
• Presence of signs of active infection or pus formation.
• Patients with a need for implants in the anterior region.
• Additional oral surgery in the region of interest.
• Need For Bone grafting.
• Pregnant and/or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Computer guided implant placement using artificial intelligence assisted designing and manufacturing	Procedure: Conventional computer guided implant placement; The virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed using the conventional CAD steps for static guide design and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
Active Comparator: Computer guided implant placement using conventional digital workflow in designing and manufacturing	Procedure: AI assisted implant placement; the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear Discrepancy	The linear implant position discrepancy between the plan and the actual implant position in millimeters will be assessed using a specialized software.	Immediate post operative
Angular Discrepancy	The angular implant position discrepancy between the plan and the actual implant position in degrees will be assessed using a specialized software.	Immediate post operative
CAD Timing	The time elapsed for AI assisted CAD, will be compared to time elapsed during conventional CAD workflow in seconds using a stopwatch.	Immediate post operative

Collaborators and Investigators

• Sponsor: Sandra Moussa Botros El Tarzi

Publications and helpful links

General Publications

• Zhou, W., Z. Liu, L. Song, C. L. Kuo and D. M. Shafer (2018). "Clinical Factors Affecting the Accuracy of Guided Implant Surgery-A Systematic Review and Meta-analysis." J Evid Based Dent Pract 18(1): 28-40.
• Younes, F., J. Cosyn, T. De Bruyckere, R. Cleymaet, E. Bouckaert and A. Eghbali (2018). "A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients." J Clin Periodontol 45(6): 721-732.
• Van de Velde, T., F. Glor and H. De Bruyn (2008). "A model study on flapless implant placement by clinicians with a different experience level in implant surgery." Clin Oral Implants Res 19(1): 66-72.
• Takács, A., E. Hardi, B. G. N. Cavalcante, B. Szabó, B. Kispélyi, Á. Joób-Fancsaly, K. Mikulás, G. Varga, P. Hegyi and M. Kivovics (2023). "Advancing accuracy in guided implant placement: A comprehensive meta-analysis: Meta-Analysis evaluation of the accuracy of available implant placement Methods." J Dent 139: 104748.
• 6. Smitkarn, P., K. Subbalekha, N. Mattheos and A. Pimkhaokham (2019). "The accuracy of single-tooth implants placed using fully digital-guided surgery and freehand implant surgery." J Clin Periodontol 46(9): 949-957.
• 5. Shujaat, S., M. Riaz and R. Jacobs (2023). "Synergy between artificial intelligence and precision medicine for computer-assisted oral and maxillofacial surgical planning." Clin Oral Investig 27(3): 897-906.
• 4. Shirmohammadi, A. and S. Ghertasi Oskouei (2023). "The growing footprint of artificial intelligence in periodontology & implant dentistry." J Adv Periodontol Implant Dent 15(1): 1-2.
• Murphy, D. C. and D. B. Saleh (2020). "Artificial Intelligence in plastic surgery: What is it? Where are we now? What is on the horizon?" Ann R Coll Surg Engl 102(8): 577-580.
• 2. Hung, K., C. Montalvao, R. Tanaka, T. Kawai and M. M. Bornstein (2020). "The use and performance of artificial intelligence applications in dental and maxillofacial radiology: A systematic review." Dentomaxillofac Radiol 49(1): 20190107.
• Ersoy, A. E., I. Turkyilmaz, O. Ozan and E. A. McGlumphy (2008). "Reliability of implant placement with stereolithographic surgical guides generated from computed tomography: clinical data from 94 implants." J Periodontol 79(8): 1339-1345.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Accuracy; Dental Implant; CAD/CAM; Implant Placement; Implant planning; Computer guided; CAIS
• Other Study ID Numbers: sandra.eltarzi1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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