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

Fundación Eduardo Anitua

Status: Completed

Conditions: Edentulous Alveolar Ridge

Treatments: Device: MATFILL (PTFE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04543292

Exp. 812/20/EC (Other Identifier)

BTI_01_EP/20/MATFILL

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

MATFILL

Experimental group

Description:

Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head.

Treatment:

Device: MATFILL (PTFE)