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

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543292
• Other study ID #: BTI_01_EP/20/MATFILL
• Secondary ID: Exp. 812/20/EC
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: September 2020
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Device:
• MATFILL (PTFE)
Filling of the prosthetic chimney with the compressed material

Locations

Country	Name	City	State
Spain	Eduardo Anitua Private Clinic	Vitoria	Alava

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua	BTI Biotechnology Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integrity of screw head	Integrity of the screw head observed in photographs	6 weeks
Primary	Integrity of screw head	Retightening after screw after unscrew	6 weeks
Secondary	Occurrence of prosthetic complications	Occurrence of prosthetic complications during follow-up	6 weeks
Secondary	Occurrence of biological complications	Occurrence of biological complications	6 weeks