Effect of Bio-activation on Epithelial and Connective Cell Adhesion to Titanium Abutments: Split Mouth Clinical Trial

The aim of this "in vivo" controlled trial is to assess soft tissue cell adhesion to titanium abutments subjected to different cleaning procedures - no treatment (as they come from the industry), and cleaning by plasma- at an early healing time.

In fact, the primary aim is Quantity and Quality of soft tissue adhesion at the microscopic level (e.g Fibronectin, Integrin-actin).

The secondary Aim - Clinical parameters and outcomes - BOP, PPD, MBL (Marginal Bone Level to check influence of plasmapp-treated abutments).

The null hypothesis of the study was that the cleaning procedure applied to implant abutments has no effect on soft tissue cell adhesion and MBL at an early healing time.

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Key information

Conditions

Missing Tooth/Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

presence of at least 4 mm of keratinized mucosa around the implants,
patients aged 18 years or older
medically healthy patients (ASA I), or patients with mild systemic disease (ASA II)
Total or partial edentulous state with space for at least 2 implants

Exclusion criteria

ASA physical status 3
severe smokers (> 10 cig/day)
patients undergoing bisphosphonate therapy
pregnant or lactating women
estrogen-related hormonal disorders or hormonal substitution therapy patients with a history of head and neck cancers and radiotherapy in this region

Treatment and study plan

the test group were placed in an Argon plasma reactor

Device

the test group were placed in an Argon plasma reactor

Primary outcomes

connective tissue coverage

Time frame: 3 months post-op
- Coverage was defined as the extent to which the abutment surface was occupied by adherent cells. It reflects the spatial distribution of cells across the surface, providing a measure of surface colonization.
Coverage was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.

Secondary outcomes

Connective tissue density

Time frame: 3 months post-op
- Density was defined as the degree of cellular accumulation in the regions where cells were present. This parameter reflects the local compactness of cells, irrespective of how widely they are spread across the surface.
Density was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.
Mean bon loss

Time frame: 1 year post-op

MBL will be measured at 1-year follow up using orthopanoramic or endo-oral Xray.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Canullo

CONTACT

[email protected]

+39393476201976‬

Sponsors and collaborators

Lead sponsor

Universita degli Studi di Genova

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 16, 2025
Registry last updated: Jul 16, 2025

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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