Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Perimplant tissue inflammation
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
- •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.
Arms & Interventions
Treated abutments
abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation
Intervention: the test group were placed in an Argon plasma reactor (Device)
Non treated abutment
Abutment without any surface treatment
Outcomes
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. 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.
Secondary Outcomes
- Connective tissue maturation(3 months after implant insertion)
- Epithelial regeneration(3 months after implant insertion)
Investigators
Paolo Pesce
Professor
Universita degli Studi di Genova