Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Perimplant tissue inflammation
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treated abutments
abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation
干预措施: the test group were placed in an Argon plasma reactor (Device)
Non treated abutment
Abutment without any surface treatment
结局指标
主要结局
Perimplant tissue inflammation
时间窗: 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.
次要结局
- Connective tissue maturation(3 months after implant insertion)
- Epithelial regeneration(3 months after implant insertion)
研究者
Paolo Pesce
Professor
Universita degli Studi di Genova