NCT06967090

Brief Summary

To compare the accuracy of surgical guided implant using AI tooth segmentation of the CBCT alone without intraoral scan to fabricate the implant guide versus conventional technique by alignment the CBCT and intraoral scan to fabricate the implant guide in posterior implant.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jun 2025

Status
not yet 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 Progress90%
Jun 2025Jul 2026

First Submitted

Initial submission to the registry

May 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 1, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

AI in guided dental implant

Outcome Measures

Primary Outcomes (3)

  • The accuracy of the placed implants

    The accuracy of the placed implants by measurements of the following: Horizontal platform deviation, (Measuring unit in millimeter) corresponding to the horizontal distance between the virtually planned and actually placed implant platforms.

    one week after surgery

  • Horizontal apex deviation, (Measuring unit in millimeter)

    corresponding to the horizontal distance between the virtually planned and placed implant apices.

    one week after surgery

  • Angular deviation, (Measuring unit in degree)

    corresponding to the angle between the virtually planned and placed implant axes.

    one week after surgery

Study Arms (2)

Study group:

ACTIVE COMPARATOR

Will use surgical guided implant using AI tooth segmentation of the CBCT alone without intraoral scan to fabricate the implant guide.

Device: Implant surgery using surgical guide

Control group:

ACTIVE COMPARATOR

Will use surgical guided implant using conventional technique and intraoral scan to fabricate the implant guide.

Device: Implant surgery using surgical guide

Interventions

Dental implant surgical guides are customized device used to position dental implants to ensure that the implant is placed in the most ideal location, angulation and depth into the bone.

Control group:Study group:

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with missing posterior teeth require implant surgery.
  • Patients have remaining teeth that can support the surgical guide.
  • The edentulous area should involve healed bone sites at least 3 months after extraction.
  • The edentulous area should have bone height of at least 10 mm from the alveolar crest to the nearest vital structure and bone width of at least 6 mm.
  • Age: patient above 18 years old.
  • All patients are in good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
  • All selected patients are non-smokers and non-alcoholics. Patients are free from temporomandibular disorders and abnormal (TMD) oral habits such as bruxism.

You may not qualify if:

  • Systemic disease that may affect bone quality.
  • Patients with poor oral hygiene and active periodontal diseases.
  • Patient with limited mouth opening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • On SW, Cho SW, Park SY, Yi SM, Park IY, Byun SH, Kim JC, Yang BE. Advancements in computer-assisted orthognathic surgery: A comprehensive review and clinical application in South Korea. J Dent. 2024 Jul;146:105061. doi: 10.1016/j.jdent.2024.105061. Epub 2024 May 9.

    PMID: 38729289BACKGROUND
  • Altalhi AM, Alharbi FS, Alhodaithy MA, Almarshedy BS, Al-Saaib MY, Al Jfshar RM, Aljohani AS, Alshareef AH, Muhayya M, Al-Harbi NH. The Impact of Artificial Intelligence on Dental Implantology: A Narrative Review. Cureus. 2023 Oct 30;15(10):e47941. doi: 10.7759/cureus.47941. eCollection 2023 Oct.

    PMID: 38034167BACKGROUND
  • Schubert O, Schweiger J, Stimmelmayr M, Nold E, Guth JF. Digital implant planning and guided implant surgery - workflow and reliability. Br Dent J. 2019 Jan 25;226(2):101-108. doi: 10.1038/sj.bdj.2019.44.

    PMID: 30679852BACKGROUND
  • Mahardawi B, Jiaranuchart S, Arunjaroensuk S, Dhanesuan K, Mattheos N, Pimkhaokham A. The Accuracy of Dental Implant Placement With Different Methods of Computer-Assisted Implant Surgery: A Network Meta-Analysis of Clinical Studies. Clin Oral Implants Res. 2025 Jan;36(1):1-16. doi: 10.1111/clr.14357. Epub 2024 Sep 10.

    PMID: 39254507BACKGROUND
  • Aghaloo T, Hadaya D, Schoenbaum TR, Pratt L, Favagehi M. Guided and Navigation Implant Surgery: A Systematic Review. Int J Oral Maxillofac Implants. 2023 May-Jun;38(suppl):7-15. doi: 10.11607/jomi.10465.

    PMID: 37436945BACKGROUND
  • Ulbrich M, Van den Bosch V, Bonsch A, Gruber LJ, Ooms M, Melchior C, Motmaen I, Wilpert C, Rashad A, Kuhlen TW, Holzle F, Puladi B. Advantages of a Training Course for Surgical Planning in Virtual Reality for Oral and Maxillofacial Surgery: Crossover Study. JMIR Serious Games. 2023 Jan 19;11:e40541. doi: 10.2196/40541.

    PMID: 36656632BACKGROUND
  • Marei HF, Abdel-Hady A, Al-Khalifa K, Al-Mahalawy H. Influence of surgeon experience on the accuracy of implant placement via a partially computer-guided surgical protocol. Int J Oral Maxillofac Implants. 2019 September/October;34(5):1177-1183. doi: 10.11607/jomi.7480. Epub 2019 Apr 1.

    PMID: 30934035BACKGROUND
  • Khaohoen A, Powcharoen W, Sornsuwan T, Chaijareenont P, Rungsiyakull C, Rungsiyakull P. Accuracy of implant placement with computer-aided static, dynamic, and robot-assisted surgery: a systematic review and meta-analysis of clinical trials. BMC Oral Health. 2024 Mar 21;24(1):359. doi: 10.1186/s12903-024-04033-y.

    PMID: 38509530BACKGROUND
  • Custodio ALN, Chrcanovic BR, Cameron A, Bakr M, Reher P. Accuracy evaluation of 3D-printed guide-assisted flapless micro-osteoperforations in the anterior mandible. Int J Comput Dent. 2022 Nov 25;25(4):387-396. doi: 10.3290/j.ijcd.b2599841.

    PMID: 35072427BACKGROUND
  • Li Y, Lyu J, Cao X, Zhou Y, Tan J, Liu X. Accuracy of a calibration method based on cone beam computed tomography and intraoral scanner data registration for robot-assisted implant placement: An in vitro study. J Prosthet Dent. 2024 Dec;132(6):1309.e1-1309.e9. doi: 10.1016/j.prosdent.2024.08.009. Epub 2024 Sep 7.

    PMID: 39245604BACKGROUND
  • Minnema J, Ernst A, van Eijnatten M, Pauwels R, Forouzanfar T, Batenburg KJ, Wolff J. A review on the application of deep learning for CT reconstruction, bone segmentation and surgical planning in oral and maxillofacial surgery. Dentomaxillofac Radiol. 2022 Sep 1;51(7):20210437. doi: 10.1259/dmfr.20210437. Epub 2022 May 23.

    PMID: 35532946BACKGROUND
  • Lahoud P, Diels S, Niclaes L, Van Aelst S, Willems H, Van Gerven A, Quirynen M, Jacobs R. Development and validation of a novel artificial intelligence driven tool for accurate mandibular canal segmentation on CBCT. J Dent. 2022 Jan;116:103891. doi: 10.1016/j.jdent.2021.103891. Epub 2021 Nov 13.

    PMID: 34780873BACKGROUND
  • Shaheen E, Leite A, Alqahtani KA, Smolders A, Van Gerven A, Willems H, Jacobs R. A novel deep learning system for multi-class tooth segmentation and classification on cone beam computed tomography. A validation study. J Dent. 2021 Dec;115:103865. doi: 10.1016/j.jdent.2021.103865. Epub 2021 Oct 26.

    PMID: 34710545BACKGROUND

Study Officials

  • Haytham Ahmed Salah Al-Mahalawy, Phd

    Head of the Department of Oral & Maxillofacial Surgery Faculty of Dentistry Fayoum University

    STUDY CHAIR
  • Nourhan Mohamed Abdelmoneim, Phd

    Lecturer of Oral & Maxillofacial Surgery Faculty of Dentistry Fayoum University

    STUDY CHAIR

Central Study Contacts

Dina Emad Rabie, Bachelor's

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 13, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05