Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery

January 16, 2026 updated by: Miguel Gómez Polo, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. Computer-guided implant surgery is associated with a known loss of accuracy when compared with virtual implant planning, due to the influence of multiple clinical and technical factors. Deviations between planned and actual implant positions remain a relevant issue in guided implant surgery. Accuracy is commonly assessed by comparing virtually planned implant positions with postoperative implant positions using linear and angular deviation measurements. From a clinical perspective, improving the accuracy of guided implant placement is particularly relevant in complete-arch rehabilitations, where small deviations may affect prosthetic fit and clinical outcomes. Metal sleeves incorporated into surgical guides may contribute to mechanical tolerance between the drilling instrument and the guide, and reducing this tolerance could potentially improve accuracy.

Justification. Despite the widespread use of guided implant surgery, limited in vivo evidence exists regarding the effect of eliminating metal sleeves from surgical guides on implant placement accuracy. Additionally, the influence of reducing the drilling channel diameter on implant deviation relative to virtual planning has not been sufficiently evaluated. This study aims to determine whether the elimination of metal sleeves and the reduction of drilling channel diameter improve the accuracy of guided implant surgery. The findings may help clarify whether the use of metal sleeves is necessary and whether reducing the drilling channel diameter compared with manufacturer standards may decrease implant deviation by minimizing the gap between the drill and the guide.

Study Design. This study is designed as a prospective, single-center, interventional split-mouth clinical trial. An intraindividual comparison will be performed between two guided surgery conditions within the same patient.

Participants. The study population will consist of 15 partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants. Eligible participants will be patients classified as ASA I or II. Patients classified as ASA III or IV will be excluded. All participants will be required to meet the predefined inclusion criteria, none of the exclusion criteria, and will be required to provide written informed consent prior to participation.

Intervention. Virtual implant planning will be performed using guided surgery software by aligning DICOM data from cone-beam computed tomography scans with STL files of the maxillae obtained through intraoral scanning. A virtual diagnostic wax-up of the immediate-loading provisional restoration will be created to guide prosthetically driven implant planning. Following virtual planning, two drilling conditions will be randomly assigned in a split-mouth manner. On one side, drilling channels will be designed with the standard diameter recommended by the manufacturer for use with metal sleeves (4.85 mm). On the contralateral side, drilling channels will be designed with a reduced diameter of 4.83 mm. Surgical guides will be digitally designed, exported as STL files, and fabricated using three-dimensional printing technology with biocompatible surgical guide resin at a resolution of 35 microns. The guides will be sterilized in an autoclave at 134 °C for 5 minutes. Dental implants will be placed using the guided surgical templates.

Outcomes Assessment. After implant placement, postoperative intraoral scans with scan bodies will be obtained, and cone-beam computed tomography scans with scan bodies will be performed following a standardized imaging protocol. The planned and postoperative datasets will be compared to evaluate differences between virtual implant planning and actual implant placement. Measurements will be performed using reverse engineering software to calculate linear and angular deviations between planned and placed implants.

Statistical Analysis. Once data collection is completed, statistical analysis will be performed. Data normality will be assessed, and a chi-square test will be used to evaluate differences between the study conditions.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Miguel A Gómez Polo, DDS, PhD
  • Phone Number: +34659390001
  • Email: mgomezpo@ucm.es

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Universidad Complutense de Madrid
        • Sub-Investigator:
          • Solange J Vasquez Ramos, DDS, MSc
        • Contact:
        • Principal Investigator:
          • Juan Ballesteros, DDS, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Drilling Diameter
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
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.
Experimental: Reduced Drilling Diameter
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Drilling Channel Diameter on Implant Placement Accuracy
Time Frame: Immediately after implant placement
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation Between Planned and Actual Implant Positions
Time Frame: Immediately after implant placement
The linear and angular deviations between the virtually planned implant positions and the actual implant positions achieved after fully guided implant surgery will be evaluated to describe overall implant placement accuracy.
Immediately after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Juan Ballesteros, DDs, MSc, Universidad Complutense de Madrid Juan Ballesteros- Martinez, DDs, MSc
  • Study Chair: Miguel A Gómez Polo, DDS, PhD, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 10, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24/764-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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