Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

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.
    


Intervention name(s): Zirconia implants with G3-coated abutments (test implants and abutments); Zirconia implants with control abutments (test implants, negative control abutments); Titanium implants with G3-coated abutments (control implants, test abutments); Titanium implants with control abutments (negative control implants and abutments); Zirconia implants and titanium implants, for histological and histomorphometric evaluation.
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Test and control interventions correspond to those usually applied in dental implantology. The "two-step protocol" will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected.; Test and control interventions correspond to those usually applied in dental implantology. The "two-step protocol" will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected.; Test and control interventions correspond to those usually applied in dental implantology. The "two-step protocol" will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected.; Test and control interventions correspond to those usually applied in dental implantology. The "two-step protocol" will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected.; 6 implants (3 tests and 3 controls) will be used to evaluate and compare osseointegration, via histological and histomorphometrical analysis, in the area of the wisdom teeth ("non useful" sites that will not interfere with the rest of the study or the patient's life) - it can only be performed in patients who no longer have these teeth. The procedure will match that described for Groups A-B-C-D. In this case, implants will only remain in the mouth for 2 months, after which they will be removed for analysis. The extraction will be performed with local anesthesia. A flap will be raised to expose the implant and, using a trephine bur (1 mm wider than the implant diameter), a bone cylinder containing the implant will be extracted. The resulting bone defect and regeneration process will be similar to those following a normal molar extraction. The flap will be sutured and primary curing is expected. A new implantation will not be carried out since in this area it is totally unnecessary.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: peri-implantitis; ceramic dental implant; non-invasive; periodontal disease; metal-free