Clinical Evaluation of Polytetrafluoroethylene (PTFE, MAT... | NCT04543292

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

NCT04543292

Sponsor

Fundación Eduardo Anitua

Status

Completed

Last Update Posted

Jun 16, 2021Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Edentulous Alveolar Ridge

Interventions

MATFILL (PTFE)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Exp. 812/20/EC	Other Identifier	AEMPS

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Nov 6, 2020Actual

Completion Date

Nov 6, 2020Actual

First Submitted Date

Sep 2, 2020

First Submission Date that Met QC Criteria

Sep 2, 2020

First Posted Date

Sep 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 16, 2021Actual

Name	Class
BTI Biotechnology Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MATFILL	Experimental	Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head.	Device: MATFILL (PTFE)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MATFILL (PTFE)	Device	Filling of the prosthetic chimney with the compressed material	MATFILL

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo Anitua, MD, DDS, PhD	Eduardo Anitua Private Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eduardo Anitua Private Clinic		Vitoria-Gasteiz	Alava	01005	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided