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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04543292
Recruitment Status : Completed
First Posted : September 10, 2020
Last Update Posted : June 16, 2021
Sponsor:
Collaborator:
BTI Biotechnology Institute
Information provided by (Responsible Party):
Fundación Eduardo Anitua

Study Description
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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.

Condition or disease Intervention/treatment Phase
Edentulous Alveolar Ridge Device: MATFILL (PTFE) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: MATFILL
Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head.
 Device: MATFILL (PTFE)
Filling of the prosthetic chimney with the compressed material


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543292


Locations
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Spain
Eduardo Anitua Private Clinic
Vitoria, Alava, Spain, 01005
Sponsors and Collaborators
Fundación Eduardo Anitua
BTI Biotechnology Institute
Investigators
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Principal Investigator: Eduardo Anitua, MD, DDS, PhD Eduardo Anitua Private Clinic
More Information
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Responsible Party: Fundación Eduardo Anitua
ClinicalTrials.gov Identifier: NCT04543292    
Other Study ID Numbers: BTI_01_EP/20/MATFILL
Exp. 812/20/EC ( Other Identifier: AEMPS )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases