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NCT Number: NCT07082088

Abutment Hydrophilicity on Soft Tissue Morphogenesis

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).

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Key information

Conditions

Missing Tooth/Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
partially edentulous state
healthy periodontal condition (also including periodontal health on reduced periodontium) according to the referent case definition

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
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.

Treatment and study plan

the test group were placed in an Argon plasma reactor

Device

the test group were placed in an Argon plasma reactor

Primary outcomes

Perimplant tissue inflammation

Time frame: 3 months after implant insertion
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.
- 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.

Secondary outcomes

Connective tissue maturation

Time frame: 3 months after implant insertion
Organization and maturation of collagen fibers in the subepithelial connective tissue. Score:

0 Immature, disorganized tissue; sparse, wavy, randomly oriented collagen fibers; abundant amorphous matrix; numerous active fibroblasts.
- Partial organization: more collagen fibers but still irregularly arranged; thin, wavy fibers; abundant amorphous matrix persists.
- Intermediate organization: initial fiber parallelism; collagen bundles alternating with matrix; fibers still partially wavy.
- Well organized: parallel collagen bundles along the epithelial plane; reduced interstitial spaces; reduced amorphous matrix; fewer fibroblasts.
- Complete maturation: dense, regular collagen bundles; consistent and continuous orientation; dense, stable, poorly cellular connective tissue.
Epithelial regeneration

Time frame: 3 months after implant insertion
Evaluation of thickness, continuity, and maturation of the overlying epithelium.

Scores:

0 Epithelium absent or severely discontinuous; ulcerated or completely denuded areas.
- Partial regeneration: covered zones alternating with denuded or de-epithelialized areas.
- Almost complete: continuous epithelium but with reduced thickness and/or not fully stratified cellular structure.
- Complete but thin: stratified epithelium present, with fewer cell layers than normal.
- Complete, stratified epithelium; well-developed with multiple layers, perfect continuity, and regular morphology.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Canullo

CONTACT

[email protected]

+393476201976‬

Sponsors and collaborators

Lead sponsor

Paolo Pesce

Other

Registry information

Official study title

Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 24, 2025
Registry last updated: Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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