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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversita degli Studi di Genova

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

ASA physical status 3

severe smokers (> 10 cig/day)

patients undergoing bisphosphonate therapy

pregnant or lactating women

Trial design

Design model

Crossover

Treatments tested in this trial

  • the test group were placed in an Argon plasma reactor

    Device

    the test group were placed in an Argon plasma reactor

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Machined Abutment - controlNo intervention 0 interventions
Group B: Plasma abutment - testExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

connective tissue coverage

• 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.

Time frame
3 months post-op

Secondary outcomes

1

Connective tissue density

• 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.

Time frame
3 months post-op
2

Mean bon loss

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

Time frame
1 year post-op

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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