Soft Tissue Integration of Different Abutment Surfaces

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge; Soft Tissue Healing
• Intervention / Treatment: Procedure: Argon plasma pre-treated abutment insertion; Procedure: abutment insertion

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italy/Rome
    • Rome, Italy/Rome, Italy, 00198
      • Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient requiring implant supported restoration.
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:

1. Patients who smoke over 10 cigarettes/day
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): December 18, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: DD-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No