Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287346
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-23
Brief Title:
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece
Sponsor:
CeraRoot SL
Organization:
CeraRoot SL
Study Overview
Official Title:
5-Years Multicentric Prospective Post-Market Clinical Follow-up PMCF Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece
Status:
RECRUITING
Status Verified Date:
2024-02
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:
240101
Brief Summary:
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth The main questions it aims to answer are
Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece TL variant
What are the complications associated to the procedure and differences between the two groups
Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece TL variant
What are the complications associated to the procedure and differences between the two groups
Detailed Description:
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models 16112112143434L and the different sub-variants one-piece versus two-piece
The geographic population of study will be the patients in two different dental centers located in Barcelona Spain and Boulder Colorado USA The intended population as described in the device instruction for use 3 is Intended Population All fully-grown patients men or women requiring dental reconstruction using dental implants and who have no contraindications The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies
The geographic population of study will be the patients in two different dental centers located in Barcelona Spain and Boulder Colorado USA The intended population as described in the device instruction for use 3 is Intended Population All fully-grown patients men or women requiring dental reconstruction using dental implants and who have no contraindications The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None