Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Edentulous Alveolar Ridge
- Sponsor
- Fundación Eduardo Anitua
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Integrity of screw head
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old
- •Clinical need for the placement of a implant-supported dental prosthesis
- •Clinical need for the filling of the prosthetic chimney
- •Signing informed consent
Exclusion Criteria
- •Inability of follow-up
Outcomes
Primary Outcomes
Integrity of screw head
Time Frame: 6 weeks
Retightening after screw after unscrew
Secondary Outcomes
- Occurrence of prosthetic complications(6 weeks)
- Occurrence of biological complications(6 weeks)