Abutment Hydrophilicity on Soft Tissue Morphogenesis

NCT07082088 | Not Yet Recruiting

• 1 other identifier: hydrophilicity
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effect of abutment surface bioactivation via argon plasma treatment on peri-implant soft tissue healing and integration in adult patients undergoing implant therapy. The main questions it aims to answer are: Does argon plasma treatment of healing abutments improve the quality and organization of peri-implant connective tissue compared to untreated abutments? Does the treatment influence histological parameters such as epithelial regeneration, vascularization, inflammatory infiltrate, and keratin layer thickness? Researchers will compare plasma-treated healing abutments to untreated machined-surface abutments to determine whether the bioactivated surface improves soft tissue morphogenesis. Participants will: Undergo implant placement with immediate connection of either a treated or untreated healing abutment. Have plaque and bleeding indices recorded at 3 months. Undergo a soft tissue biopsy at 3 months for histological analysis (including evaluation of inflammation, connective tissue, epithelial morphology, vascularization, and keratinization).

Conditions

Missing Tooth/Teeth

Outcome Measures

Primary Outcomes (1)

• Perimplant tissue inflammation

  Evaluation of density and distribution of inflammatory cells (lymphocytes, plasma cells, granulocytes, macrophages) in the peri-epithelial connective tissue will be evaluated and a score will be used; 0 Massive infiltrate, diffusely present throughout the section; dense cellular aggregates; severely disturbed connective architecture. 1\. Intense infiltrate, present in most of the section but not fully diffuse; clearly visible focal aggregates. 2 Moderate infiltrate, 3 Minimal infiltrate; isolated low-density cellular foci; connective tissue mostly unaffected. 4 No recognizable inflammatory infiltrate; only resident normal cells present.

  3 months after implant insertion

Secondary Outcomes (2)

• Connective tissue maturation

  3 months after implant insertion

• Epithelial regeneration

  3 months after implant insertion

Study Arms (2)

Treated abutments

EXPERIMENTAL

abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation

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

Non treated abutment

NO INTERVENTION

Abutment without any surface treatment

Interventions

the test group were placed in an Argon plasma reactor DEVICE

the test group were placed in an Argon plasma reactor

Treated abutments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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)
• partially edentulous state
• healthy periodontal condition (also including periodontal health on reduced periodontium) according to the referent case definition

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
• untreated periodontitis (pocket depth 4mm with positive bleeding on probing)
• multiple gingival recession
• patients with a history of head and neck cancers and radiotherapy in this region.

Sponsors & Collaborators

• Paolo Pesce: 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

+393476201976‬; luigicanullo@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 24, 2025
• Study Start: July 31, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07