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

NCT ID: NCT07069231

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Missing Tooth/Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Machined Abutment - control

The control group received MUA without plasma treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

the test group were placed in an Argon plasma reactor

Intervention Type DEVICE

the test group were placed in an Argon plasma reactor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the test group were placed in an Argon plasma reactor

the test group were placed in an Argon plasma reactor

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universita degli Studi di Genova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paolo Pesce

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luigi Canullo

Role: CONTACT

+39393476201976‬

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 37853303 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Abutment adhesion

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.