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Clinical Trials in Italy / NCT06808724
Recruiting Observational

Clinical Influence of Different Surface Treatments on Implant Stabiity

NCT06808724 · tracked via the Priya Life Science Italy tracker
Sponsor
International Piezosurgery Academy
Phase
Observational
Started
2025-01-31
Last updated
2025-02-05

Condition(s) studied

Edentulous Alveolar Ridge

Investigational drug(s) / intervention(s)

implant with ozonated oilnon-activated implantimplant with plasma activation

implant with ozonated oil: 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.

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. 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.

implant with plasma activation: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age older than 18 years old; * Indication for an implant-supported rehabilitation in the left and right upper premolar/first molar areas; * The area in which the implants will be placed must have had at least 6 months of healing; * No use of grafts or bone substitutes following tooth extraction; * Bone volume measuring at least 10 mm in height and 6 mm in width; * Absence or decision to not wear a removable prosthesis during the healing period; * Patients with good and stable oral hygiene; * Signed informed consent form. Exclusion Criteria: * Acute myocardial infarction within the previous six months; * Uncontrolled bleeding disorders; * Uncontrolled diabetes (HBA1c \> 7.5%); * Radiotherapy in the head-neck area in the previous 48 months; * Immunocompromised patients (es. AIDS / chemotherapy); * Current or previous treatment with antiresorptive drugs via intravenous injection; * Psychological or psychiatric disease; * Alcohol and /or drugs abuse; * Heavy smokers (more than 10 cigarettes / day); * Plaque index \>20% and/or bleeding on probing \>10% * Pregnant or breastfeeding patients; * Patients refusing to participate in follow-up checks.

Primary outcome measure(s)

  • Implant primary stability measured with RFA device (Osstell) — Immediately after implant placement
    Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden)
  • Implant primary stability in Newton — Immediately after implant placement
    Insertion torque

Trial sites (1)

FacilityCityRegionStatus
University of Trieste Trieste TS Recruiting

More International Piezosurgery Academy trials in Italy

Effect Of Cavitation In Post-Extractive Socket Healing Recruiting
Alveolar Ridge Preservation: Biologically-oriented Alveolar Ridge Preservation Vs Modified Periosteal Inhibition Active, not recruiting
Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability Active, not recruiting
Alveolar Ridge Preservation After Tooth Extraction Active, not recruiting
Use of Radiomics in the Evaluation of Bone Quality After Alveolar Ridge Preservation Enrolling by invitation

Other trials for the same condition

Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix Active, not recruiting
Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808724 on ClinicalTrials.gov ↗ ← All trials in Italy