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Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery

NCT07364006 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

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

  • Miguel A Gómez Polo, DDS, PhD · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-06-01
Completion
2026-08-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364006 on ClinicalTrials.gov