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

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.