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Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.
Patients that need implant supported restoration were recruited for this study. At baseline a specific abutment was screwed at 20 N.Two months following healing abutment placement clinical measurements were evaluated.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abutments with machine surface | Placebo Comparator | abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um |
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| abutments with rough Ultrathin Threaded Microsurface | Placebo Comparator | abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm |
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| argon plasma pre-treated (PT) abutments | Experimental | abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma |
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| non treated abutments | Placebo Comparator | abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argon plasma pre-treated abutment insertion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Histological and immunohistochemical assessment | soft peri-implant tissues and abutment were harvested and histologically processedSpecialized stainings (hematoxylin eosin and picrocirious red) coupled with immunohistochemistry (vimentin, collagen, and CK10) were performed to assess soft tissue inflammation and healing, as well as the collagen content keratinization. | 2 months after abutment placement |
| Plaque index (PI) | PI scores were recorded in 6 points around each abutment, averaged, and expressed in %. PI was evaluated with a score of 0,1,2, 3 depending on the amount of plaque at each site. | 2 months after abutment placement |
| Bleeding on probing (BoP) | BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable | 2 months after abutment placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Odont.Associato Dr.P.Cicchese E L.Canullo | Rome | Italy/Rome | 00198 | Italy |
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Participants received either abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um (surface roughness: Ra=0.2 and Sa=0.11) or abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm (surface roughness: Ra=0.62 and Sa=0.60) abutments allocated to the test group were placed in an Argon plasma reactor (Diener Electronic GmbH, Jettingen, Germany) for decontamination and activation. in control group were allocated argon plasma non-treated abutmentsParticipants underwent 2-level randomization for allocation of abutments with different surface configurations and experimental treatment using permuted block technique to limit any selection bias. Allocation concealment was preserved by sealing the tested abutments in sterile envelopes sealed in opaque sleeves opened at the time of the second surgical step.
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the histologist was blinded
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| abutment insertion | Procedure | the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment |
|