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.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Device: MATFILL (PTFE)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain, 01005
      • Eduardo Anitua Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrity of screw head	Integrity of the screw head observed in photographs	6 weeks
Integrity of screw head	Retightening after screw after unscrew	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of prosthetic complications	Occurrence of prosthetic complications during follow-up	6 weeks
Occurrence of biological complications	Occurrence of biological complications	6 weeks

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Collaborators: BTI Biotechnology Institute
• Investigators: Principal Investigator: Eduardo Anitua, MD, DDS, PhD, Eduardo Anitua Private Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: BTI_01_EP/20/MATFILL; Exp. 812/20/EC (Other Identifier: AEMPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No