Peri-ImplantitisINPERIONCT03977714
Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)
A study testing Zirconia implants with G3-coated abutments (test implants and abutments) and Zirconia implants and titanium implants, for histological and histomorphometric evaluation. in people with Peri-Implantitis, run by Nanoker Research S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Zirconia implants with G3-coated abutments (test implants and abutments) and Zirconia implants and titanium implants, for histological and histomorphometric evaluation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2019to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Solution for Periodontal and Peri-implant Diseases
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.
Read more
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.
- Conditions
- Peri-Implantitis
- Being tested
- 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.
- Keywords
- peri-implantitis, ceramic dental implant, non-invasive, periodontal disease, metal-free
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia implants with G3-coated abutments (test implants and abutments)Device
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.
Zirconia implants with control abutments (test implants, negative control abutments)Device
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.
Titanium implants with G3-coated abutments (control implants, test abutments)Device
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.
Titanium implants with control abutments (negative control implants and abutments)Device
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.
Zirconia implants and titanium implants, for histological and histomorphometric evaluation.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - test implant and abutment | Experimental | 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. Receives: Device: Zirconia implants with G3-coated abutments (test implants and abutments) |
| Group B - test implant and control abutment | Experimental | 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. Receives: Device: Zirconia implants with control abutments (test implants, negative control abutments) |
| Group C - control implant and test abutment | Experimental | 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. Receives: Device: Titanium implants with G3-coated abutments (control implants, test abutments) |
| Group D - control implant and abutment | Active comparator | 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. Receives: Device: Titanium implants with control abutments (negative control implants and abutments) |
| Group E - test and control implants | Experimental | 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. Receives: Device: Zirconia implants and titanium implants, for histological and histomorphometric evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant performance verification: implant survival rate. Change will be assessed.
Number of functional implants vs. number of implants inserted.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Secondary outcomes (1)
Prosthetic complications. Change will be assessed.
Assessment of parameters that may act as predisposing factors for prosthetic complications (checklist: smoker; drinking habits, etc.).
Measured: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start2 Aug 2019
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanoker Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission, ICOA Noroeste SLP, National Research Council, Spain, Experior
- Responsible party
- Sponsor
- Investigators
- Roberto López Píriz, MD, DDS, PhD, Principal investigator, ICOA Noroeste SLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977714
- Sponsor's protocol ID
- INPERIO
- Other IDs
- 812065-INPERIO, 18/497-R_P, 712/18/EC
- Acronym
- INPERIO
- Status last verified
- Jul 2022
- First submitted
- 28 May 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Solution for Periodontal and Peri-implant Diseases
- ClinicalTrials.gov ID
- NCT03977714
- Acronym / sponsor ID
- INPERIO / INPERIO
- Conditions
- Peri-Implantitis
- Keywords
- peri-implantitis, ceramic dental implant, non-invasive, periodontal disease, metal-free
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nanoker Research S.L.Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission, ICOA Noroeste SLP, National Research Council, Spain, Experior
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A - test implant and abutment | Experimental | Device: Zirconia implants with G3-coated abutments (test implants and abutments)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. |
| Group B - test implant and control abutment | Experimental | Device: Zirconia implants with control abutments (test implants, negative control abutments)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. |
| Group C - control implant and test abutment | Experimental | Device: Titanium implants with G3-coated abutments (control implants, test abutments)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. |
| Group D - control implant and abutment | Active comparator | Device: Titanium implants with control abutments (negative control implants and abutments)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. |
| Group E - test and control implants | Experimental | Device: Zirconia implants and titanium implants, for histological and histomorphometric evaluation.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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia implants with G3-coated abutments (test implants and abutments)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. | Device | Group A - test implant and abutment |
| Zirconia implants with control abutments (test implants, negative control abutments)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. | Device | Group B - test implant and control abutment |
| Titanium implants with G3-coated abutments (control implants, test abutments)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. | Device | Group C - control implant and test abutment |
| Titanium implants with control abutments (negative control implants and abutments)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. | Device | Group D - control implant and abutment |
| Zirconia implants and titanium implants, for histological and histomorphometric evaluation.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. | Device | Group E - test and control implants |
Primary outcome
Implant performance verification: implant survival rate. Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Number of functional implants vs. number of implants inserted.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Osseointegration quality: implant stability will be assessed via metal instrument tapping - the transmitted sound will indicate good/bad osseointegration.
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Osseointegration quantity: distance from the implant platform to the first bone contact (assessed via probing).
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Osseointegration quantity: bone to implant contact (BIC) (assessed via standard parallel periapical radiographs).
Implant performance verification: osseointegration (in vivo). Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Osseointegration quantity: bone density/quality (assessed via standard parallel periapical radiographs).
Implant performance verification: osseointegration (ex vivo).
Time frame: 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.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Assessment of peri-implant inflammation sign: bleeding on probing (BOP).
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
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.
G3-coated abutment performance in peri-implantitis prevention. Change will be assessed.
Time frame: 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.
1 secondary outcome
Prosthetic complications. Change will be assessed.
Time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto López Píriz, MD, DDS, PhD principal investigator
ICOA Noroeste SLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia implants with G3-coated abutments (test implants and abutments) and Zirconia implants and titanium implants, for histological and histomorphometric evaluation. in people with Peri-Implantitis, run by Nanoker Research S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant performance verification: implant survival rate. Change will be assessed. (time frame: Day 1 (abutment connection), 3 months, 6 months, 1 year.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.