NCT06028750

Dynamic Navigation vs. the Freehand Method

Accuracy of Dental Implant Placement Using Dynamic Navigation or the Freehand Method: a Randomized Controlled Clinical Trial in Novice Operators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.

Detailed description

Randomized clinical trial with 2 parallel treatment groups. Eligible patients will be randomized with a 1:1 ratio to one of 2 possible parallel treatment groups: * Group 1: Nobel Replace Conical Connection® placed freehand. * Group 2: Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA). PRIMARY OBJECTIVE: \- To evaluate in novice surgeons the accuracy of the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement. SECONDARY OBJECTIVES: * To evaluate overall surgical time with the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) compared to freehand implant placement in inexperienced surgeons. * To evaluate Patient Reported Outcomes Measures (PROMs) during implant treatment with navigation systems performed by novice surgeons.

Conditions

• Dental Implants

Interventions

Type	Name	Description
PROCEDURE	Dynamic Computer Assisted Surgery	Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide
PROCEDURE	Freehand	Freehand implant placement

Timeline

• Start date: 2023-09-08
• Primary completion: 2024-07-16
• Completion: 2024-11-01
• First posted: 2023-09-08
• Last updated: 2025-07-29

Locations

1 site across 1 country: Spain