Soft Tissue Integration of Different Abutment Surfaces

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment

Conditions
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Edentulous Alveolar Ridge, Soft Tissue Healing

Intervention / Treatment
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* Procedure: Argon plasma pre-treated abutment insertion
* Procedure: abutment insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring implant supported restoration. Residual alveolar bone width of edentulous jaw of > 8mm. Keratinized mucosa width of >6mm Males and females between 18-80 years old Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%) Patients that are willing to sign an informed consent and participate in a clinical study Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation Exclusion Criteria: Patients who smoke over 10 cigarettes/day Pregnancy (confirmed by verbal inquiry) Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4. Patients taking bisphosphonates Any sites where an implant already failed sites Untreated Periodontitis Dental sites with acute infections Chronic inflammatory diseases of the oral cavity Autoimmune diseases (cortisone intake) Allergy declared to one or more medicaments to be used during treatment Alcoholics patients and/or drug addicts. History or malignant tumours of the maxillary sinus History of local radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: abutments with machine surface<br>abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um | Procedure: Argon plasma pre-treated abutment insertion<br>* 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.<br>Procedure: abutment insertion<br>* the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment<br>|
| Placebo Comparator: abutments with rough Ultrathin Threaded Microsurface<br>abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm | Procedure: Argon plasma pre-treated abutment insertion<br>* 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.<br>Procedure: abutment insertion<br>* the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment<br>|
| Experimental: argon plasma pre-treated (PT) abutments<br>abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma | Procedure: Argon plasma pre-treated abutment insertion<br>* 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.<br>|
| Placebo Comparator: non treated abutments<br>abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment. | Procedure: abutment insertion<br>* the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |