CClinicalTrials.gg
CompletedNCT04543292Updated Jun 16, 2021

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

An interventional study of MATFILL (PTFE) in Edentulous Alveolar Ridge, sponsored by Fundación Eduardo Anitua. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Fundación Eduardo Anitua · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Edentulous Alveolar Ridge

Browse trials for

03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's enrollment of 4 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

Fundación Eduardo Anitua is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Inability of follow-up
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    MATFILL

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

    Device: MATFILL (PTFE)

Interventions

  • DeviceMATFILL (PTFE)

    Filling of the prosthetic chimney with the compressed material

06

What researchers measure

Primary outcomes

  1. Integrity of screw head

    Integrity of the screw head observed in photographs

    Time frame: 6 weeks

  2. Integrity of screw head

    Retightening after screw after unscrew

    Time frame: 6 weeks

Secondary outcomes

  1. Occurrence of prosthetic complications

    Occurrence of prosthetic complications during follow-up

    Time frame: 6 weeks

  2. Occurrence of biological complications

    Occurrence of biological complications

    Time frame: 6 weeks

07

Study locations

1 site
  • Eduardo Anitua Private Clinic
    Vitoria, Alava 01005, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04543292
Lead sponsor
Fundación Eduardo Anitua
Collaborators
BTI Biotechnology Institute
Responsible party
Sponsor
First posted
Sep 10, 2020
Start date
Sep 1, 2020
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020
Last update
Jun 16, 2021

Study contacts

Eduardo Anitua, MD, DDS, PhD
principal investigator · Eduardo Anitua Private Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion