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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
24
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.
ICOA Noroeste SLP
Las Rozas de Madrid, Madrid, Spain
Implant performance verification: implant survival rate. Change will be assessed.
Number of functional implants vs. number of implants inserted.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Osseointegration quality: implant stability will be assessed via metal instrument tapping - the transmitted sound will indicate good/bad osseointegration.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Osseointegration quantity: distance from the implant platform to the first bone contact (assessed via probing).
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Osseointegration quantity: bone to implant contact (BIC) (assessed via standard parallel periapical radiographs).
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Osseointegration quantity: bone density/quality (assessed via standard parallel periapical radiographs).
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Implant performance verification: osseointegration (ex vivo).
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.
Time frame: 2 months after implantation.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
Assessment of peri-implant inflammation sign: bleeding on probing (BOP).
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
Assessment of gingival alteration sign: gingival clinical attachment level (CAL). 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.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
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.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Prosthetic complications. Change will be assessed.
Assessment of parameters that may act as predisposing factors for prosthetic complications (checklist: smoker; drinking habits, etc.).
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
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