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

Primary Purpose

Edentulous Alveolar Ridge

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

MATFILL (PTFE)

About this trial

This is an interventional prevention trial for Edentulous Alveolar Ridge

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Eduardo Anitua Private Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MATFILL

Arm Description

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

Outcomes

Primary Outcome Measures

Integrity of screw head

Integrity of the screw head observed in photographs

Integrity of screw head

Retightening after screw after unscrew

Secondary Outcome Measures

Occurrence of prosthetic complications

Occurrence of prosthetic complications during follow-up

Occurrence of biological complications

Full Information

NCT ID

NCT04543292

First Posted

September 2, 2020

Last Updated

June 15, 2021

Sponsor

Fundación Eduardo Anitua

Collaborators

BTI Biotechnology Institute

1. Study Identification

Unique Protocol Identification Number

NCT04543292

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

November 6, 2020 (Actual)

Study Completion Date

November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación Eduardo Anitua

Collaborators

BTI Biotechnology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Alveolar Ridge

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MATFILL

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MATFILL (PTFE)

Intervention Description

Filling of the prosthetic chimney with the compressed material

Primary Outcome Measure Information:

Title

Integrity of screw head

Description

Integrity of the screw head observed in photographs

Time Frame

6 weeks

Title

Integrity of screw head

Description

Retightening after screw after unscrew

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Occurrence of prosthetic complications

Description

Occurrence of prosthetic complications during follow-up

Time Frame

6 weeks

Title

Occurrence of biological complications

Description

Occurrence of biological complications

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Anitua, MD, DDS, PhD

Organizational Affiliation

Eduardo Anitua Private Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eduardo Anitua Private Clinic

City

Vitoria

State/Province

Alava

ZIP/Postal Code

01005

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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