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Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO) — INPERIO  

Peri-Implantitis Clinical Trial

Official title:
Non-invasive Solution for Periodontal and Peri-implant Diseases

Clinical Trial Summary

DESCRIPTION: The Investigational Product "A-Ce toughened TZP nanocomposite implant" is a Medical Device (MD) intended for the dental rehabilitation of edentulous sites with fixed prosthesis. The "G3®-coated NK2® abutment" is a MD intended for the prevention of peri-implant bone loss due to peri-implantitis. The MD are for dental use and will be used exclusively on subjects who have signed an informed consent form and by approved study investigators. OBJECTIVES: (a) To evaluate the safety and performance of the "A-Ce toughened TZP nanocomposite Implant" for its intended medical application purpose in the context of successful osseointegration of zirconia-based dental implants. (b) To evaluate the safety and performance of the "G3®-coated NK2® abutment" for its intended purpose in the context of peri-implantitis prevention. (c) To obtain the regulatory CE Mark Certification status for both medical devices. TYPE OF INVESTIGATION: Randomized double-blind (patient, appraiser) controlled study. CENTER/COUNTRY: Instituto de Cirugía Oral Avanzada (ICOA), Madrid, Spain GROUPS: Group A: 30 zirconia implants with 30 G3-coated abutments (test implant and abutment) Group B: 30 test implants with 30 uncoated (control) abutments Group C: 30 Ti implants (control) with 30 test abutments Group D: 30 control implants with 30 control abutments Group E: 3 test implants and 3 control implants, for histological/histomorphometric evaluation. COMPARATIVE DEVICE: Commercial Ti dental implant. STATISTICAL METHODOLOGY: H0 : INPERIO performs worse (with statistical significance) than the commercial devices. - Test implants achieve a higher failure rate than Ti implants. - The clinical osseointegration parameter values are worse with statistical significance for test implants than for control implants. - Histological and histomorphometric analysis shows worse quality and quantity of osseointegration for test implants than for Ti implants. H1: There is no statistical significance between INPERIO and the commercial solution or INPERIO performs better (with statistical significance) than the commercial Ti implants. - Test implants achieve the same failure rate or less than Ti implants. - The clinical osseointegration parameter values are no different or are better with statistical significance for test implants than for control implants. - The histological and histomorphometric analysis shows a similar or better quality and quantity of osseointegration for test implants than for Ti implants.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03977714
Study type Interventional
Source Nanoker Research S.L.
Contact
Status Completed
Phase N/A
Start date August 2, 2019
Completion date July 4, 2022
View Details
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