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

NCT07069231 | Not Yet Recruiting

• 1 other identifier: Abutment adhesion
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Missing Tooth/Teeth

Outcome Measures

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.

  3 months post-op

Secondary Outcomes (2)

• Connective tissue density

  3 months post-op

• Mean bon loss

  1 year post-op

Study Arms (2)

Machined Abutment - control

NO INTERVENTION

The control group received MUA without plasma treatment.

Plasma abutment - test

EXPERIMENTAL

.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.

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

Interventions

the test group were placed in an Argon plasma reactor DEVICE

the test group were placed in an Argon plasma reactor

Plasma abutment - test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Related Publications (1)

• Canullo L, Donato A, Savadori P, Radovanovic S, Iacono R, Rakic M. Effect of argon plasma abutment activation on soft tissue healing: RCT with histological assessment. Clin Implant Dent Relat Res. 2024 Feb;26(1):226-236. doi: 10.1111/cid.13286. Epub 2023 Oct 18.

  PMID: 37853303 BACKGROUND

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Luigi Canullo

CONTACT

+39393476201976‬; luigicanullo@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07