Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-28 @ 10:34 PM
Study NCT ID:
NCT03198520
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
REFRAME RPD Post-Market Clinical Study
Sponsor:
Solvay Dental 360
Organization:
Study Overview
Official Title:
REFRAME RPD Post-Market Clinical Study
Status:
COMPLETED
Status Verified Date:
2020-11
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:
None
Brief Summary:
To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM polymer Removable Partial Denture (RPD) for 8 weeks.
Detailed Description:
Cohort study conducted in the United States \& United Kingdom to assess Oral Health Related Quality of Life (OHRQoL) in patients receiving the study polymer Removable Partial Denture (RPD) as compared to their baseline Cobalt Chrome (CoCr) Removable Partial Denture (RPD) Oral Health Quality of Life (OHRQoL).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: