Health TrialsbyHealthPanel

Clinical Influence of Different Surface Treatments on Implant Stabiity

ConditionEdentulous Alveolar Ridge
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInternational Piezosurgery Academy

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • implant with ozonated oil

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Test2 interventions
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

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
2

Implant primary stability in Newton

Insertion torque

Time frame
Immediately after implant placement

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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)
3

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
4

NPRS

Numeric Pain Rating Scale between the treatments (minimum 0, maximum 10)

Time frame
7 days after implant insertion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Piezosurgery Academy

Lead sponsor

University of Trieste

Collaborator

Source ClinicalTrials.gov
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