An observational study in Edentulous Alveolar Ridge, sponsored by International Piezosurgery Academy. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by International Piezosurgery Academy · Observational
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The goal of this observational study is to monitor, within a cohort of patients requiring rehabilitation at two different sites in the premolar area, the primary and secondary stability of implants placed with different surface treatments: vacuum-plasma activation, ozonated oil and non-activated implants.
The primary outcome measures included primary implant stability, assessed through insertion torque and the Implant Stability Quotient (ISQ).
Secondary outcome measures included the pattern of implant secondary stability during the first 90 days post-implant placement (ISQ), implant survival after one year, NPRS comparison between treatments at one week postoperatively, and any complications or adverse events.
As an additional objective, the study aimed to assess whether a relationship existed between implant surface treatment and early marginal bone loss. Marginal bone levels were measured at three time points: immediately after surgery (T0), upon delivery of prosthetic rehabilitation (T1), and after one year of loading (T2). The distance between the implant platform and the bone crest was measured at each interval, on both the mesial and distal aspects of the implant. A positive value was assigned when the bone crest was coronal to the implant platform, whereas a negative value was assigned when the bone crest was apical to the implant platform.
Study Design: Observational, prospective, non-profit case-control study.
Study Population: The study will be conducted in an outpatient hospital setting.
Enrollment Procedure: All patients meeting the inclusion and exclusion criteria will be enrolled in the study after receiving the Information Sheet and providing written informed consent.
Patients seeking implant-supported rehabilitation due to the absence of at least two teeth were initially evaluated with a periapical radiograph of the selected sites to assess residual bone height adequacy. If sufficient bone height was observed, a second-level radiographic examination using Cone Beam Computed Tomography (CBCT) was performed to confirm the adequacy of bone volume for implant rehabilitation.
Surgical Phase: Following local anesthesia (mepivacaine HCl 2% with epinephrine 1:100,000), a minimally invasive full-thickness flap was elevated. The same surgeon performed all procedures. Implant site preparation was performed using twist drills. In one group, ozonated oil (Surgy O3, Biosanity) was applied to the implant surface and then the implant was inserted into the prepared osteotomy site. A transepithelial abutment was then attached using a torque wrench, tightened to 30 Ncm. In the second group, implant underwent vacuum-plasma activation immediately before insertion (Plasma X Motion, Megagen, Gyeongbuk, South Korea) and then it was inserted into the prepared osteotomy site. A transepithelial abutment was then attached using a torque wrench, tightened to 30 Ncm. In the control group, the implant was inserted without any treatment. A transepithelial abutment was then attached using a torque wrench, tightened to 30 Ncm. Single monofilament synthetic polypropylene 4.0 sutures were used to close the flaps.
A postoperative radiographic assessment was conducted to verify correct implant positioning.
A blinded operator measured ISQ values for each implant in two directions: vestibular-palatal and mesio-distal. Measurements were taken at the abutment level three times per direction, and the averages were used for statistical analysis.
ISQ measurements were performed using a Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden).
Follow-up: After surgery, a follow-up visit was scheduled after one week for suture removal, soft tissue healing assessment, and ISQ measurements. Additional follow-ups occurred at 14, 21, 28, 42, 56, and 90 days, with the same parameters reassessed at each visit.
All implants were restored with screw-retained single metal-ceramic crowns four months after surgery and were followed up for at least 12 months after prosthetic loading. Radiographic check-ups were conducted at 6 months and 1 year.
For the sample size calculation, it was assumed that the minimal clinically relevant difference between the groups was 5 points on the ISQ scale, with a standard deviation of 5. Using an 80% power and a 95% significance level, the calculation yielded a sample size of approximately 16 participants per group (rounded to the next whole number). This ensures sufficient power to detect the anticipated difference between the groups.
Statistical Plan: Statistical analysis will be performed using a computerized statistical package (SigmaStat 3.5, SPSS Inc., Germany). Data will be expressed as mean ± standard deviation or median (interquartile range) for parametric and non-parametric values, respectively.
International Piezosurgery Academy is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
After investigating general and local anamnesis, which included evaluation of systemic illnesses and potential allergies, a dental visit was conducted to formulate a specific treatment plan.
If the patient was deemed eligible for the research protocol, an additional periapical radiograph was obtained for each selected site to assess the adequacy of residual bone height.
If the available bone height appeared to be sufficient, a second-level radiographic exam, a Cone Beam Computed Tomography (CBCT), was performed to evaluate whether the bone volume was adequate for supporting implant rehabilitation.
For patients requiring tooth extraction, this second assessment was performed after six months of healing after extraction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ozonated oil / plasma activation
Procedure: implant with ozonated oil · Procedure: implant with plasma activation
No surface treatment
Procedure: non-activated implant
Following local anesthesia (mepivacaine HCl 2% with epinephrine 1:100,000), a minimally invasive full-thickness flap will be elevated. Implant site preparation will be performed with twist drills. Ozonated oil (Surgy O3) will be applied to the implant surface and then the implant will be inserted into the prepared osteotomy site. A 3 mm high transepithelial abutment will be then screwed using a torque wrench, tightened to 30 Ncm. Single monofilament synthetic polypropylene 4.0 sutures will be used to close the flaps.
Following local anesthesia (mepivacaine HCl 2% with epinephrine 1:100,000), a minimally invasive full-thickness flap will be elevated. Implant site preparation will be performed with twist drills. In the control group, the implant will be inserted without any treatment. A 3 mm high transepithelial abutment will be then attached using a torque wrench, tightened to 30 Ncm. Single monofilament synthetic polypropylene 4.0 sutures will be used to close the flaps.
Following local anesthesia (mepivacaine HCl 2% with epinephrine 1:100,000), a minimally invasive full-thickness flap will be elevated. Implant site preparation will be performed with twist drills. Implant will undergo vacuum-plasma activation immediately before insertion (Plasma X Motion, Megagen, Gyeongbuk, South Korea) and then it will be inserted into the prepared osteotomy site. A transepithelial abutment will then be attached using a torque wrench, tightened to 30 Ncm. Single monofilament synthetic polypropylene 4.0 sutures will be used to close the flaps.
Implant primary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: Immediately after implant placement
Implant primary stability in Newton
Insertion torque
Time frame: Immediately after implant placement
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 7 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 14 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 21 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 28 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 42 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 56 days after implant insertion
Implant secondary stability measured with RFA device (Osstell)
Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
Time frame: 90 days after implant insertion
Peri-implant marginal bone level stability
The distance between implant platform and bone crest was measured at each time interval, on both mesial and distal aspects of the implant. A positive value was assigned when the bone crest was coronal to the implant platform, whereas a negative value was assigned when the bone crest was apical to the implant platform. MBL has no defined minimum or maximum value.
Time frame: Immediately after surgery
Peri-implant marginal bone level stability
The distance between implant platform and bone crest was measured at each time interval, on both mesial and distal aspects of the implant. A positive value was assigned when the bone crest was coronal to the implant platform, whereas a negative value was assigned when the bone crest was apical to the implant platform. MBL has no defined minimum or maximum value.
Time frame: Upon delivery of prosthetic rehabilitation (6 months after surgery)
Peri-implant marginal bone level stability
The distance between implant platform and bone crest was measured at each time interval, on both mesial and distal aspects of the implant. A positive value was assigned when the bone crest was coronal to the implant platform, whereas a negative value was assigned when the bone crest was apical to the implant platform. MBL has no defined minimum or maximum value.
Time frame: One year of loading
NPRS
Numeric Pain Rating Scale between the treatments (minimum 0, maximum 10)
Time frame: 7 days after implant insertion
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.
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International Piezosurgery Academy