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OpenTrials
Completed

NCT Number: NCT04543292

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eduardo Anitua Private Clinic

Vitoria-Gasteiz, Alava, 01005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MATFILL (PTFE)

Device

Filling of the prosthetic chimney with the compressed material

Primary outcomes

  1. Integrity of screw head

    Time frame: 6 weeks

    Integrity of the screw head observed in photographs

  2. Integrity of screw head

    Time frame: 6 weeks

    Retightening after screw after unscrew

Secondary outcomes

  1. Occurrence of prosthetic complications

    Time frame: 6 weeks

    Occurrence of prosthetic complications during follow-up

  2. Occurrence of biological complications

    Time frame: 6 weeks

    Occurrence of biological complications

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Collaborators

  • BTI Biotechnology Institute

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2020
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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