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Abutment Hydrophilicity on Soft Tissue Morphogenesis

P

Paolo Pesce

Status

Not yet enrolling

Conditions

Missing Tooth/Teeth

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07082088
hydrophilicity

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Treated abutments
Experimental group
Description:
abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation
Treatment:
Device: the test group were placed in an Argon plasma reactor
Non treated abutment
No Intervention group
Description:
Abutment without any surface treatment

Trial contacts and locations

0

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Central trial contact

Luigi Canullo

Data sourced from clinicaltrials.gov

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