Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-06-21
2022-06-30
Brief Summary
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Detailed Description
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Endopoints of the study:
Histological outcomes at 2 using traditional histological staining (ematossilin/eosin) Immunohistological outcomes at 2 using different stainings. Postoperative complications. Comparison between the histological outcomes and the preoperative clinical evaluation of the sites
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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abutments with machine surface
abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um
Argon plasma pre-treated abutment insertion
abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.
abutment insertion
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
abutments with rough Ultrathin Threaded Microsurface
abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm
Argon plasma pre-treated abutment insertion
abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.
abutment insertion
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
argon plasma pre-treated (PT) abutments
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma
Argon plasma pre-treated abutment insertion
abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.
non treated abutments
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment.
abutment insertion
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
Interventions
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Argon plasma pre-treated abutment insertion
abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. In order to restrict any post-treatment contamination; abutments were inserted immediately after the end of the plasma process. The reactor was set at 75 W of power and -10 MPa of pressure for 12 min.
abutment insertion
the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment
Eligibility Criteria
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Inclusion Criteria
2. Residual alveolar bone width of edentulous jaw of \> 8mm.
3. Keratinized mucosa width of \>6mm
4. Males and females between 18-80 years old
5. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
6. Patients that are willing to sign an informed consent and participate in a clinical study
7. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
8. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation
Exclusion Criteria
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts.
12. History or malignant tumours of the maxillary sinus
13. History of local radiation therapy
18 Years
85 Years
ALL
Yes
Sponsors
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Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
OTHER
Responsible Party
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Luigi Canullo
principal investigator; DDS PHD
Locations
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Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Rome, Italy/Rome, Italy
Countries
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Other Identifiers
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DD-02
Identifier Type: -
Identifier Source: org_study_id
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