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Recruiting NCT07364006

Accuracy of Metal Sleeve-Free Fully Guided Implant Surgery

Trial Parameters

Condition Edentulism
Sponsor Universidad Complutense de Madrid
Study Type INTERVENTIONAL
Phase N/A
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-01
Completion 2026-06-01
Interventions
Standard Drilling Channel Metal Sleeve-Free Surgical GuideReduced drilling channel Metal Sleeve-Free Surgical Guide

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.

Eligibility Criteria

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.

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