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Completed

NCT Number: NCT05821673

Soft Tissue Integration of Different Abutment Surfaces

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy/Rome, 00198, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

abutment insertion

Procedure

the abutments assigned to the control group were screwed onto the implants without receiving argon plasma pretreatment

Primary outcomes

  1. Histological and immunohistochemical assessment

    Time frame: 2 months after abutment placement

    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. Plaque index (PI)

    Time frame: 2 months after abutment placement

    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.

  3. Bleeding on probing (BoP)

    Time frame: 2 months after abutment placement

    BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable

Sponsors and collaborators

Lead sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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