Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028750
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-05-08
Brief Title:
Dynamic Navigation vs the Freehand Method
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
Official Title:
Accuracy of Dental Implant Placement Using Dynamic Navigation or the Freehand Method a Randomized Controlled Clinical Trial in Novice Operators
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None