Clinical Influence of Different Surface Treatments on Implant Stabiity

NCT06808724 | Recruiting

• 1 other identifier: IMPLANT SURFACE MODIFICATIONS
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (2)

• 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)

  Immediately after implant placement

• Implant primary stability in Newton

  Insertion torque

  Immediately after implant placement

Secondary Outcomes (7)

• Implant secondary stability measured with RFA device (Osstell)

  7 days after implant insertion

• Implant secondary stability measured with RFA device (Osstell)

  14 days after implant insertion

• Implant secondary stability measured with RFA device (Osstell)

  21 days after implant insertion

• Implant secondary stability measured with RFA device (Osstell)

  28 days after implant insertion

• Implant secondary stability measured with RFA device (Osstell)

  42 days after implant insertion

Other Outcomes (4)

• Peri-implant marginal bone level stability

  Immediately after surgery

• Peri-implant marginal bone level stability

  Upon delivery of prosthetic rehabilitation (6 months after surgery)

• Peri-implant marginal bone level stability

  One year of loading

Study Arms (2)

Test

ozonated oil / plasma activation

Procedure: implant with ozonated oil; Procedure: implant with plasma activation

Control

No surface treatment

Procedure: non-activated implant

Interventions

implant with ozonated oil PROCEDURE

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.

Test

non-activated implant PROCEDURE

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.

Control

implant with plasma activation PROCEDURE

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.

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• University of Trieste: collaborator

Study Sites (1)

University of Trieste

Trieste, TS, 34125, Italy

RECRUITING

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Claudio Stacchi, Dott.

CONTACT

+39 0403992254; claudio@stacchi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 5, 2025
• Study Start: January 31, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)