Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542562
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Accuracy of Fully Guided Versus Half Guided Implant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla A Split-mouth Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesisThe primary outcome measure will be the accuracy of implant placement which will be evaluated using cone-beam computed tomography CBCT scans
Detailed Description:
Study Design
This will be a Split mouth randomized controlled trial RCT study 16 patients missing teeth in the maxillary upper jaw and eligible for dental implant treatment will be recruited
Interventions will be randomly assigned to the right or the left side of the arch
Group 1 will undergo fully guided dental implant surgery Group 2 will undergo partially guided dental implant surgery
Study Duration
The total duration of the study is estimated to be 5 months Recruitment and enrollment of patients 1 months Dental implant surgery 3 months Data analysis and manuscript preparation 1 months
The key steps are
Recruit 16 eligible patients missing teeth in the maxillary jaw Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group
Perform CBCT cone-beam computed tomography scans before and after the implant surgery for both groups
Assess the accuracy of implant placement in both groups using the CBCT data Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups
Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants
The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation
This will be a Split mouth randomized controlled trial RCT study 16 patients missing teeth in the maxillary upper jaw and eligible for dental implant treatment will be recruited
Interventions will be randomly assigned to the right or the left side of the arch
Group 1 will undergo fully guided dental implant surgery Group 2 will undergo partially guided dental implant surgery
Study Duration
The total duration of the study is estimated to be 5 months Recruitment and enrollment of patients 1 months Dental implant surgery 3 months Data analysis and manuscript preparation 1 months
The key steps are
Recruit 16 eligible patients missing teeth in the maxillary jaw Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group
Perform CBCT cone-beam computed tomography scans before and after the implant surgery for both groups
Assess the accuracy of implant placement in both groups using the CBCT data Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups
Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants
The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None