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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07069231
Enrollment
20
Registered
2025-07-16
Start date
2025-07-15
Completion date
2025-10-30
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missing Tooth/Teeth

Brief summary

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.

Interventions

the test group were placed in an Argon plasma reactor

Sponsors

Universita degli Studi di Genova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
connective tissue coverage3 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

MeasureTime frameDescription
Connective tissue density3 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 loss1 year post-opMBL will be measured at 1-year follow up using orthopanoramic or endo-oral Xray.

Contacts

Primary ContactLuigi Canullo
luigicanullo@yahoo.com+39393476201976‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026