Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery

NCT07364006 | Recruiting

• 1 other identifier: 24/764-E
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the in vivo accuracy of fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. The study is designed as a split-mouth clinical trial and will be conducted in partially or fully edentulous adult patients requiring complete-arch rehabilitation with dental implants. The primary objective of the study is to assess the accuracy of implant placement by comparing the virtually planned implant positions with the actual clinical positions achieved after guided surgery. Accuracy will be evaluated by analyzing linear and angular deviations between planned and placed implants. Participants will undergo a fully guided implant placement procedure using metal sleeve-free surgical guides. Two different drilling channel diameters (standard and reduced) will be randomly assigned in a split-mouth manner. Postoperative intraoral scans and cone-beam computed tomography (CBCT) scans with scan bodies will be obtained to register the final implant positions. The planned and achieved implant positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the use of metal sleeve-free guides and reduced drilling diameters influences implant placement accuracy.

Conditions

Edentulism

Keywords

Guided implant surgery; Dental implants; Surgical guide accuracy; Metal sleeve-free surgical guides; 3D-printed surgical guides

Outcome Measures

Primary Outcomes (1)

• Effect of Drilling Channel Diameter on Implant Placement Accuracy

  Implant placement accuracy will be compared between implants placed using fully guided surgical guides with a standard drilling channel diameter (4.85 mm) and those placed using a reduced drilling channel diameter (4.83 mm). Linear deviations at the coronal and apical implant levels, as well as angular deviations of the implant axis, relative to the virtual implant planning will be measured to determine whether differences in accuracy exist between both drilling conditions.

  Immediately after implant placement

Secondary Outcomes (1)

• Deviation Between Planned and Actual Implant Positions

  Immediately after implant placement

Study Arms (2)

Standard Drilling Diameter

EXPERIMENTAL

Implant placement using metal sleeve-free 3D-printed surgical guides with a standard drilling channel diameter (4.85 mm).

Device: Standard Drilling Channel Metal Sleeve-Free Surgical Guide

Reduced Drilling Diameter

EXPERIMENTAL

Implant placement using metal sleeve-free 3D-printed surgical guides with a reduced drilling channel diameter (4.83 mm).

Device: Reduced drilling channel Metal Sleeve-Free Surgical Guide

Interventions

Standard Drilling Channel Metal Sleeve-Free Surgical Guide DEVICE

Fully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with a standard drilling channel diameter in a split-mouth design.

Standard Drilling Diameter

Reduced drilling channel Metal Sleeve-Free Surgical Guide DEVICE

Fully guided dental implant surgery performed using 3D-printed surgical guides without metal sleeves. The guides are designed based on virtual implant planning and used to place dental implants with reduced drilling channel diameter in a split-mouth design.

Reduced Drilling Diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants.
• Patients classified as ASA I or ASA II.
• Adult patients aged 18 years or older.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Patients classified as ASA III or ASA IV.
• Patients with medical conditions that contraindicate dental implant surgery.
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (13)

• Gomez-Polo M, Ballesteros J, Padilla PP, Pulido PP, Revilla-Leon M, Ortega R. Merging intraoral scans and CBCT: a novel technique for improving the accuracy of 3D digital models for implant-supported complete-arch fixed dental prostheses. Int J Comput Dent. 2021 Jun 4;24(2):117-123.

  PMID: 34085497 BACKGROUND

• Chen Z, Li J, Ceolin Meneghetti P, Galli M, Mendonca G, Wang HL. Does guided level (fully or partially) influence implant placement accuracy at post-extraction sockets and healed sites? An in vitro study. Clin Oral Investig. 2022 Aug;26(8):5449-5458. doi: 10.1007/s00784-022-04512-y. Epub 2022 May 2.

  PMID: 35499656 BACKGROUND

• Pessoa R, Siqueira R, Li J, Saleh I, Meneghetti P, Bezerra F, Wang HL, Mendonca G. The Impact of Surgical Guide Fixation and Implant Location on Accuracy of Static Computer-Assisted Implant Surgery. J Prosthodont. 2022 Feb;31(2):155-164. doi: 10.1111/jopr.13371. Epub 2021 May 10.

  PMID: 33904640 BACKGROUND

• Shah NP, Khanna A, Pai AR, Sheth VH, Raut SR. An evaluation of virtually planned and 3D-printed stereolithographic surgical guides from CBCT and digital scans: An in vitro study. J Prosthet Dent. 2022 Sep;128(3):436-442. doi: 10.1016/j.prosdent.2020.12.035. Epub 2021 Feb 12.

  PMID: 33583616 BACKGROUND

• El Kholy K, Janner SFM, Schimmel M, Buser D. The influence of guided sleeve height, drilling distance, and drilling key length on the accuracy of static Computer-Assisted Implant Surgery. Clin Implant Dent Relat Res. 2019 Feb;21(1):101-107. doi: 10.1111/cid.12705. Epub 2018 Dec 27.

  PMID: 30589502 BACKGROUND

• Hernandez-Margarit P, Palacios-Banuelos R, Roig M, Altuna P, Blasi A. Digital workflow for designing an interim implant-supported restoration with an optimal emergence profile in an open-source software program. J Prosthet Dent. 2024 Nov;132(5):857-862. doi: 10.1016/j.prosdent.2022.10.013. Epub 2022 Dec 6.

  PMID: 36494239 BACKGROUND

• Derksen W, Wismeijer D, Flugge T, Hassan B, Tahmaseb A. The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning. A prospective cohort study. Clin Oral Implants Res. 2019 Oct;30(10):1005-1015. doi: 10.1111/clr.13514. Epub 2019 Sep 9.

  PMID: 31330566 BACKGROUND

• Adams CR, Ammoun R, Deeb GR, Bencharit S. Influence of Metal Guide Sleeves on the Accuracy and Precision of Dental Implant Placement Using Guided Implant Surgery: An In Vitro Study. J Prosthodont. 2023 Jan;32(1):62-70. doi: 10.1111/jopr.13503. Epub 2022 Mar 22.

  PMID: 35257456 BACKGROUND

• Abduo J, Lau D. Effect of Manufacturing Technique on the Accuracy of Surgical Guides for Static Computer-Aided Implant Surgery. Int J Oral Maxillofac Implants. 2020 Sep/Oct;35(5):931-938. doi: 10.11607/jomi.8186.

  PMID: 32991643 BACKGROUND

• Henprasert P, Dawson DV, El-Kerdani T, Song X, Couso-Queiruga E, Holloway JA. Comparison of the Accuracy of Implant Position Using Surgical Guides Fabricated by Additive and Subtractive Techniques. J Prosthodont. 2020 Jul;29(6):534-541. doi: 10.1111/jopr.13161. Epub 2020 May 6.

  PMID: 32147893 BACKGROUND

• Putra RH, Yoda N, Astuti ER, Sasaki K. The accuracy of implant placement with computer-guided surgery in partially edentulous patients and possible influencing factors: A systematic review and meta-analysis. J Prosthodont Res. 2022 Jan 11;66(1):29-39. doi: 10.2186/jpr.JPR_D_20_00184. Epub 2021 Jan 26.

  PMID: 33504723 BACKGROUND

• Oh KC, Park JM, Shim JS, Kim JH, Kim JE, Kim JH. Assessment of metal sleeve-free 3D-printed implant surgical guides. Dent Mater. 2019 Mar;35(3):468-476. doi: 10.1016/j.dental.2019.01.001. Epub 2019 Jan 23.

  PMID: 30685109 BACKGROUND

• Kernen F, Kramer J, Wanner L, Wismeijer D, Nelson K, Flugge T. A review of virtual planning software for guided implant surgery - data import and visualization, drill guide design and manufacturing. BMC Oral Health. 2020 Sep 10;20(1):251. doi: 10.1186/s12903-020-01208-1.

  PMID: 32912273 BACKGROUND

Study Officials

• Juan Ballesteros, DDs, MSc

  Universidad Complutense de Madrid Juan Ballesteros- Martinez, DDs, MSc

  PRINCIPAL INVESTIGATOR

• Miguel A Gómez Polo, DDS, PhD

  Universidad Complutense de Madrid

  STUDY CHAIR

Central Study Contacts

Miguel A Gómez Polo, DDS, PhD

CONTACT

+34659390001; mgomezpo@ucm.es

Solange J Vasquez Ramos, DDS, MSc

CONTACT

solvasqu@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of conservative dentistry and prosthodontics

Model Details: Split-mouth design with intraindividual comparison of two drilling channel diameters using metal sleeve-free surgical guides.

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 23, 2026
• Study Start: October 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (1)