Edentulous Alveolar Ridge
Conditions
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.
Interventions
DEVICEMATFILL (PTFE)
Filling of the prosthetic chimney with the compressed material
Sponsors
BTI Biotechnology Institute
Fundación Eduardo Anitua
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrity of screw head | 6 weeks | Integrity of the screw head observed in photographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of prosthetic complications | 6 weeks | Occurrence of prosthetic complications during follow-up |
| Occurrence of biological complications | 6 weeks | Occurrence of biological complications |
Countries
Spain
Outcome results
None listed