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

N/ANot Yet RecruitingNCT07069231

Universita degli Studi di Genova20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Missing Tooth/Teeth

Interventions

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Mean bon loss

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

Time frame: 1 year post-op