Effect of Bio-activation on Epithelial and Connective Cell Adhesion to Titanium Abutments: Split Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- connective tissue coverage
研究概览
简要总结
The aim of this "in vivo" controlled trial is to assess soft tissue cell adhesion to titanium abutments subjected to different cleaning procedures - no treatment (as they come from the industry), and cleaning by plasma- at an early healing time.
In fact, the primary aim is Quantity and Quality of soft tissue adhesion at the microscopic level (e.g Fibronectin, Integrin-actin).
The secondary Aim - Clinical parameters and outcomes - BOP, PPD, MBL (Marginal Bone Level to check influence of plasmapp-treated abutments).
The null hypothesis of the study was that the cleaning procedure applied to implant abutments has no effect on soft tissue cell adhesion and MBL at an early healing time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 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)
- •Total or partial edentulous state with space for at least 2 implants
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 patients with a history of head and neck cancers and radiotherapy in this region
结局指标
主要结局
connective tissue coverage
时间窗: 3 months post-op
• Coverage was defined as the extent to which the abutment surface was occupied by adherent cells. It reflects the spatial distribution of cells across the surface, providing a measure of surface colonization. Coverage was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.
次要结局
- Connective tissue density(3 months post-op)
- Mean bon loss(1 year post-op)
研究者
Paolo Pesce
Prof.
Universita degli Studi di Genova