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

Nanoker Research

Status: Completed

Conditions: Peri-Implantitis

Treatments: Device: Zirconia implants with control abutments (test implants, negative control abutments); Device: Titanium implants with G3-coated abutments (control implants, test abutments); Device: Titanium implants with control abutments (negative control implants and abutments); Device: Zirconia implants and titanium implants, for histological and histomorphometric evaluation.; Device: Zirconia implants with G3-coated abutments (test implants and abutments)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03977714

812065-INPERIO (Other Grant/Funding Number)

712/18/EC (Other Identifier)

INPERIO

18/497-R_P (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 5 patient groups

Group A - test implant and abutment

Experimental group

Description:

Zirconia implant and G3-coated abutment (test implant and abutment). Dental sites that potentially qualify for dental implant rehabilitation will be randomly assigned to either the test group (zirconia implants) or the control group (titanium implants). Also, G3-coated and control (non-coated) abutments will be equally distributed on test and control implants, to discriminate between peri-implantitis prevention due to the G3-coating or due to the specific implant characteristics. This is a split-mouth study so that each participant can act as his or her own control and to allow between and within group comparisons.

Treatment:

Device: Zirconia implants with G3-coated abutments (test implants and abutments)

Group B - test implant and control abutment

Experimental group

Description:

Zirconia implant and control abutment (test implant, negative control abutment). Dental sites that potentially qualify for dental implant rehabilitation will be randomly assigned to either the test group (zirconia implants) or the control group (titanium implants). Also, G3-coated and control (non-coated) abutments will be equally distributed on test and control implants, to discriminate between peri-implantitis prevention due to the G3-coating or due to the specific implant characteristics. This is a split-mouth study so that each participant can act as his or her own control and to allow between and within group comparisons.

Treatment:

Device: Zirconia implants with control abutments (test implants, negative control abutments)

Group C - control implant and test abutment

Experimental group

Description:

Titanium implant and G3-coated abutment (control implant, test abutment). Dental sites that potentially qualify for dental implant rehabilitation will be randomly assigned to either the test group (zirconia implants) or the control group (titanium implants). Also, G3-coated and control (non-coated) abutments will be equally distributed on test and control implants, to discriminate between peri-implantitis prevention due to the G3-coating or due to the specific implant characteristics. This is a split-mouth study so that each participant can act as his or her own control and to allow between and within group comparisons.

Treatment:

Device: Titanium implants with G3-coated abutments (control implants, test abutments)

Group D - control implant and abutment

Active Comparator group

Description:

Titanium implant and control abutment (negative control implant and abutment). Dental sites that potentially qualify for dental implant rehabilitation will be randomly assigned to either the test group (zirconia implants) or the control group (titanium implants). Also, G3-coated and control (non-coated) abutments will be equally distributed on test and control implants, to discriminate between peri-implantitis prevention due to the G3-coating or due to the specific implant characteristics. This is a split-mouth study so that each participant can act as his or her own control and to allow between and within group comparisons.

Treatment:

Device: Titanium implants with control abutments (negative control implants and abutments)

Group E - test and control implants

Experimental group

Description:

Zirconia implant and titanium implant for histological and histomorphometric evaluation. This study will be performed in the area of the wisdom teeth (a "non useful" site that will not interfere with the rest of the study or with the patient's life), so it can only be performed in patients who no longer have these teeth. The procedure will match the procedures described for Groups A-B-C-D. Group E implants will only remain in the mouth for 2 months, after which they will be removed for further analysis. The removal of these implants, for the patient, has exactly the same implications as a normal molar extraction.

Treatment:

Device: Zirconia implants and titanium implants, for histological and histomorphometric evaluation.