Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571812
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
An Observational Study of the TSX Dental Implant System Xpresso
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Observational Clinical Study of the Safety Effectiveness and Clinical Performance of the TSX Dental Implant System
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Xpresso
Brief Summary:
A prospective observational multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery The patients will come back for follow-up evaluations yearly for 2 years
Detailed Description:
This will be a prospective observational multicenter study All implants will be placed in the maxilla or mandible The patient will either have a temporary prosthesis placed out of occlusion immediately during the same implant placement visit or within 48 hours or have a temporary or definitive prosthesis placed between 3-16 weeks following implant Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery All restorations will utilize the full range of the ZimVie prosthetic systems The implant system will be evaluated yearly for 2 years
Patients who are in need of treatment with dental implants in the maxilla andor mandible Those patients with tooth sites having prior failed implants or in need of implant revisions or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion
A total of 62 implants will be placed across all participating sites It is anticipated to have 60 patients although one patient may contribute more than 1 implant
Patients who are in need of treatment with dental implants in the maxilla andor mandible Those patients with tooth sites having prior failed implants or in need of implant revisions or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion
A total of 62 implants will be placed across all participating sites It is anticipated to have 60 patients although one patient may contribute more than 1 implant
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