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Clinical Trials/NCT04543292
NCT04543292
Completed
N/A

Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.

Fundación Eduardo Anitua1 site in 1 country4 target enrollmentSeptember 1, 2020

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
November 6, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fundación Eduardo Anitua
Responsible Party
Sponsor

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)

Study Sites (1)

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