non-invasive solution for periodontal and peri-implant diseases (inperio)

Conditions: Peri-Implantitis

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.


Eligibility criteria:
inclusion criteria: * males/females of age 18-80. * availability for the 18 months duration of the clinical trial. * subject able and willing to follow study procedures and instructions. * subject read, understood and signed an informed consent form. * participants in need of dental implant treatment and that meet one of the following criteria: * moderate to advanced periodontitis. * history of dental loss attributed to periodontitis. * risk factors associated with periodontitis (tobacco consumption, poor oral hygiene, diabetes patients outside of the ideal range control (hba1c \<7)). * good general health at time of inclusion. * subjects willing to disclose information on medication. exclusion criteria: * female patients who report being pregnant or lactating, or who are of childbearing potential and are not using hormonal, barrier methods of birth control or abstinence. * subject chronically treated (≥ two weeks) with any medication known to affect inflammation or periodontal status six months prior to enrollment or during the study. * subject necessitating antibiotic for 1 month during the study. * gross oral pathology. * participation in any other clinical study or test panel within one month prior to entry into the study. * history of neoplastic disease requiring the use of chemotherapy. * patients with history of renal failure or chronic renal diseases. * patients affected by chronic liver diseases. * patients with severe or uncontrolled metabolic bone disorders. * conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for undergoing surgery, or could prevent study completion or interfere with the analysis of the results, such as a history of non-compliance or unreliability. * history of local radiation therapy.

Keywords: peri-implantitis ceramic dental implant non-invasive periodontal disease metal-free