NCT04543292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

June 16, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 2, 2020

Last Update Submit

June 15, 2021

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Occurrence of prosthetic complications

    6 weeks

  • Occurrence of biological complications

    6 weeks

Study Arms (1)

MATFILL

EXPERIMENTAL

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

Device: MATFILL (PTFE)

Interventions

MATFILL (PTFE)DEVICE

Filling of the prosthetic chimney with the compressed material

MATFILL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo Anitua Private Clinic

Vitoria-Gasteiz, Alava, 01005, Spain

Location

Study Officials

  • Eduardo Anitua, MD, DDS, PhD

    Eduardo Anitua Private Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 10, 2020

Study Start

September 1, 2020

Primary Completion

November 6, 2020

Study Completion

November 6, 2020

Last Updated

June 16, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)