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

Not Applicable

Completed

• Conditions: Edentulous Alveolar Ridge
• Interventions: Device: MATFILL (PTFE)

• Registration Number: NCT04543292
• Lead Sponsor: Fundación Eduardo Anitua

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 available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MATFILL	MATFILL (PTFE)	Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head.

Primary Outcome Measures

Name	Time	Method
Integrity of screw head	6 weeks	Retightening after screw after unscrew

Secondary Outcome Measures

Name	Time	Method
Occurrence of prosthetic complications	6 weeks	Occurrence of prosthetic complications during follow-up
Occurrence of biological complications	6 weeks	Occurrence of biological complications

Trial Locations

Locations (1)

Eduardo Anitua Private Clinic; 🇪🇸 Vitoria, Alava, Spain