Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513767
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks for Use in Dental Prostheses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicentre Single-group Target-value Clinical Investigation Evaluating the Safety and Efficacy of Zirconia Ceramic Blocks for All-ceramic Dentures for Use in Dental Prostheses
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:
The goal of this clinical trial is to use the investigational device Zirconia Dental Ceramics to perform dental prosthesis in Patients with permanent teeth The main question it aims to answer is
Is the safety and efficacy of the investigational device Zirconia Dental Ceramics adequate to meet the requirements for clinical use
Participants will use the investigational device Zirconia Dental Ceramics to perform dental prosthesis and then complete a 12-month follow-up after prostheses During the follow-up periodparticipants will assess their satisfactionwhile the investigator will assess the efficacy indices of prosthesis survival rate prosthesis success rate and prosthesis quality
Is the safety and efficacy of the investigational device Zirconia Dental Ceramics adequate to meet the requirements for clinical use
Participants will use the investigational device Zirconia Dental Ceramics to perform dental prosthesis and then complete a 12-month follow-up after prostheses During the follow-up periodparticipants will assess their satisfactionwhile the investigator will assess the efficacy indices of prosthesis survival rate prosthesis success rate and prosthesis quality
Detailed Description:
The study aims to provide clinical evidence for the use of the investigational product zirconia dental ceramic in dental restorations
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