Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)
- Conditions
- Peri-Implantitis
- Registration Number
- NCT03977714
- Lead Sponsor
- Nanoker Research S.L.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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Males/females of age 18-80.
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Availability for the 18 months duration of the clinical trial.
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Subject able and willing to follow study procedures and instructions.
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Subject read, understood and signed an informed consent form.
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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)).
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Good general health at time of inclusion.
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Subjects willing to disclose information on medication.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Implant performance verification: osseointegration (in vivo). Change will be assessed. Day 1 (abutment connection), 3 months, 6 months, 1 year. Osseointegration quantity: bone density/quality (assessed via standard parallel periapical radiographs).
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed. Day 1 (abutment connection), 3 months, 6 months, 1 year. Assessment of crestal bone loss. Peri-implantitis is defined as bone loss around implants, so crestal bone loss will be assessed using the gold standard parallel X-Ray technique to evaluate any changes in bone to implant contact (BIC) at both mesial and distal aspects of all implants.
Implant performance verification: implant survival rate. Change will be assessed. Day 1 (abutment connection), 3 months, 6 months, 1 year. Number of functional implants vs. number of implants inserted.
Implant performance verification: osseointegration (ex vivo). 2 months after implantation. Please refer to Arms and Interventions, Experimental: Group E. For ethical reasons, this sample size is limited to six (6) implants, 3 test and 3 controls. Trephined blocks containing the explanted implants will be stored in a 5% formaldehyde solution (pH 7). They will be immersed in a 4% formaldehyde and 1% calcium solution and processed for ground sectioning following the Donath \& Breuner methods. Each implant block will be individualized, embedded in methyl-methacrylate and stained with combined Harris Haematoxyline and Wheatley. The analysis will be performed using a transmitted light microscope equipped with a digital camera. Results will be inferred to clinical osseointegration data, which is the way to assess osseointegration in everyday chairside practice.
- Secondary Outcome Measures
Name Time Method Prosthetic complications. Change will be assessed. Day 1 (abutment connection), 3 months, 6 months, 1 year. Assessment of parameters that may act as predisposing factors for prosthetic complications (checklist: smoker; drinking habits, etc.).
Trial Locations
- Locations (1)
ICOA Noroeste SLP
🇪🇸Las Rozas, Madrid, Spain
ICOA Noroeste SLP🇪🇸Las Rozas, Madrid, Spain