Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04543292
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2020-09-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Sponsor:
Fundación Eduardo Anitua
Organization:
Study Overview
Official Title:
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Status:
COMPLETED
Status Verified Date:
2020-09
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:
Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Exp. 812/20/EC | OTHER | AEMPS | View |