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

University of Genoa (UniGe)

Status: Not yet enrolling

Conditions: Missing Tooth/Teeth

Treatments: Device: the test group were placed in an Argon plasma reactor

Study type: Interventional

Funder types: Other

Identifiers

NCT07069231

Abutment adhesion

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Machined Abutment - control

No Intervention group

Description:

The control group received MUA without plasma treatment.

Plasma abutment - test

Experimental group

Description:

.The MUA allocated to the test group will be placed in a plasma reactor (Plasmapp, South Korea) for decontamination and activation of the surface. In order to restrict any post-treatment contamination; abutments will be inserted immediately after the end of the plasma process.

Treatment:

Device: the test group were placed in an Argon plasma reactor