Clinical trial NCT03977714: Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)
Official title: Non-invasive Solution for Periodontal and Peri-implant Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: peri-implantitis
ceramic dental implant
non-invasive
periodontal disease
metal-free
Lead sponsor: Nanoker Research S.L.
Sponsor class: INDUSTRY
Collaborators: name: Horizon 2020 - European Commission
name: ICOA Noroeste SLP
name: National Research Council, Spain
name: Experior
First posted: 2019-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Implant performance verification: implant survival rate. Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: Implant performance verification: osseointegration (in vivo). Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: Implant performance verification: osseointegration (in vivo). Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: Implant performance verification: osseointegration (in vivo). Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: Implant performance verification: osseointegration (in vivo). Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: Implant performance verification: osseointegration (ex vivo).
timeFrame: 2 months after implantation.
measure: G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
measure: G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Secondary outcomes:
measure: Prosthetic complications. Change will be assessed.
timeFrame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Other outcomes:
Locations:
city: Las Rozas
country: Spain
facility: ICOA Noroeste SLP
state: Madrid
Study officials:
affiliation: ICOA Noroeste SLP
name: Roberto López Píriz, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: