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Not yet recruitingNCT07069231Updated Jul 16, 2025

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

An interventional study of the test group were placed in an Argon plasma reactor in Missing Tooth/Teeth, sponsored by Universita degli Studi di Genova. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Universita degli Studi di Genova · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Missing Tooth/Teeth

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • No intervention
    Machined Abutment - control

    The control group received MUA without plasma treatment.

  • Experimental
    Plasma abutment - test

    .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

  • Devicethe test group were placed in an Argon plasma reactor

    the test group were placed in an Argon plasma reactor

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 37853303 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07069231
Lead sponsor
Universita degli Studi di Genova
Responsible party
Paolo Pesce (Prof., Universita degli Studi di Genova) — Principal investigator
First posted
Jul 16, 2025
Start date
Jul 15, 2025 (estimated)
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Jul 16, 2025

Study contacts

Luigi Canullo
Contact
luigicanullo@yahoo.com
+39393476201976‬

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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