Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07364006

Evaluation of Accuracy in Fully Guided Dental Implant Surgery Using 3D-Printed Surgical Guides Without Metal Sleeves: A Split-Mouth In Vivo Study

Led by Universidad Complutense de Madrid · Updated on 2026-01-23

15

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of fully guided dental implant surgery using 3D-printed surgical guides that do not have metal sleeves. This study focuses on adult patients who are partially or fully edentulous and require complete-arch rehabilitation with dental implants. The goal is to compare the planned implant positions with the actual positions after surgery, measuring linear and angular deviations to understand how well the surgery matches the virtual plan. The study uses a split-mouth design, where each participant receives two types of surgical guides with different drilling channel diameters: a standard diameter (4.85 mm) and a slightly reduced diameter (4.83 mm). These guides are digitally designed and fabricated with biocompatible resin using 3D printing technology. After virtual planning using cone-beam computed tomography and intraoral scans, implants are placed using these metal sleeve-free guides, and the accuracy of placement with each drilling channel size is compared. Participants will undergo implant placement using the assigned surgical guides, followed by postoperative intraoral and cone-beam CT scans with scan bodies to capture the final implant positions. Researchers will analyze the difference between planned and actual implant placement using three-dimensional software to measure deviations. This study includes statistical analysis of these differences and aims to assess whether reducing drilling channel diameter improves implant accuracy. The total study duration extends through the postoperative assessment immediately after implant placement.

CONDITIONS

Brief Title

Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Partially or fully edentulous patients needing fixed complete-arch dental implants
  • Patients classified as ASA I or ASA II
  • Adults aged 18 years or older
  • Ability to understand study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Patients classified as ASA III or ASA IV
  • Medical conditions that prevent dental implant surgery
  • Inability or unwillingness to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and informed consent

Implementation

Duration - Single day for implant placement

Participants undergo fully guided dental implant surgery using 3D-printed surgical guides without metal sleeves. Two different drilling channel diameters are used in a split-mouth design within the same participant to compare accuracy.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Immediately after implant placement

After implant placement, participants receive postoperative intraoral scans and cone-beam computed tomography scans to assess implant placement accuracy.

1 post-operative imaging visit (in-person)

Trial Site Locations

Total: 1 location

1

Universidad Complutense de Madrid

Madrid, Madrid, Spain, 28040

Actively Recruiting

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Research Team

M

Miguel A Gómez Polo, DDS, PhD

S

Solange J Vasquez Ramos, DDS, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Merging intraoral scans and CBCT: a novel technique for improving the accuracy of 3D digital models for implant-supported complete-arch fixed dental prostheses.

Miguel Gómez-Polo, Juan Ballesteros, Pedro Perales Padilla...

https://pubmed.ncbi.nlm.nih.gov/34085497

Does guided level (fully or partially) influence implant placement accuracy at post-extraction sockets and healed sites? An in vitro study.

Zhaozhao Chen, Junying Li, Priscila Ceolin Meneghetti...

https://pubmed.ncbi.nlm.nih.gov/35499656

The Impact of Surgical Guide Fixation and Implant Location on Accuracy of Static Computer-Assisted Implant Surgery.

Roberto Pessoa, Rafael Siqueira, Junying Li...

https://pubmed.ncbi.nlm.nih.gov/33904640

An evaluation of virtually planned and 3D-printed stereolithographic surgical guides from CBCT and digital scans: An in vitro study.

Naisargi P Shah, Anshul Khanna, Ashutosh R Pai...

https://pubmed.ncbi.nlm.nih.gov/33583616

The influence of guided sleeve height, drilling distance, and drilling key length on the accuracy of static Computer-Assisted Implant Surgery.

Karim El Kholy, Simone F M Janner, Martin Schimmel...

https://pubmed.ncbi.nlm.nih.gov/30589502

Digital workflow for designing an interim implant-supported restoration with an optimal emergence profile in an open-source software program.

Pablo Hernández-Margarit, Ricardo Palacios-Bañuelos, Miguel Roig...

https://pubmed.ncbi.nlm.nih.gov/36494239

The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning. A prospective cohort study.

Wiebe Derksen, Daniel Wismeijer, Tabea Flügge...

https://pubmed.ncbi.nlm.nih.gov/31330566

Influence of Metal Guide Sleeves on the Accuracy and Precision of Dental Implant Placement Using Guided Implant Surgery: An In Vitro Study.

Coleman R Adams, Rami Ammoun, George R Deeb...

https://pubmed.ncbi.nlm.nih.gov/35257456

Comparison of the Accuracy of Implant Position Using Surgical Guides Fabricated by Additive and Subtractive Techniques.

Pantip Henprasert, Deborah V Dawson, Tarek El-Kerdani...

https://pubmed.ncbi.nlm.nih.gov/32147893