RecruitingNCT06808724

Clinical Influence of Different Surface Treatments on Implant Stabiity

Clinical Influence of Different Surface Treatments on Implant Stabiity: a Prospective Observational Clinical Study

Sponsor

International Piezosurgery Academy

Enrollment

32 participants

Start Date

Jan 31, 2025

Study Type

OBSERVATIONAL

Conditions

Edentulous Alveolar Ridge

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria12

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.

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Interventions

PROCEDUREimplant 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.

PROCEDUREnon-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.

PROCEDUREimplant 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.