Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620497
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
SFI Bars and Milled Bars Supporting Mandibular Overdentures Three-year Randomized Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Marginal Bone Loss Prosthetic and Mucosal Complications of Stress-free Implant Bars and Milled Bars Supporting Mandibular Overdentures Three-years Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant SFI and milled bars used to assist mandibular 4-implant overdentures after 3 years
Detailed Description:
Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge 2 implants in the canine areas and 2 implants in the first molar areas and then after 3 months patients will be randomly assigned into 2 groups 1 group 1 will include 4 participants who will receive milled bar overdentures and 2 group 2 will include 4 participants who will receive SFI bar overdentures For both groups marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion 6 months 1 year and 3 years after insertion Prosthetic and mucosal complications will be evaluated after 3 years
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