NCT07523815

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
7mo left

Started May 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Dental ImplantImplant PlacementAccuracyComputer guidedCAISImplant planningCAD/CAM

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Computer guided implant placement using artificial intelligence assisted designing and manufacturing

ACTIVE COMPARATOR
Procedure: Conventional computer guided implant placement

Computer guided implant placement using conventional digital workflow in designing and manufacturing

ACTIVE COMPARATOR
Procedure: AI assisted implant placement

Interventions

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.

Computer guided implant placement using conventional digital workflow in designing and manufacturing

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.

Computer guided implant placement using artificial intelligence assisted designing and manufacturing

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Manial, Egypt

RECRUITING

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Central Study Contacts

Sandra Moussa El Tarzi, BDS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations