A Prospective Randomized Clinical Split-mouth Study on the Influence of Implant Surface Roughness on Peri-implant Bone Stability of Implants Supporting a Mandibular Overdenture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The effect of surface roughness on long-term crestal bone remodelling.
研究概览
简要总结
This study looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. The researchers also check how these implant treatments impact patients' quality of life related to oral health after 1 year and again after 8 years.
详细描述
This split-mouth randomized controlled trial aimed to assess the effect of surface roughness on long-term crestal bone remodelling and peri-implant health, comparing hybrid and moderately rough implants. As a secondary aim, Oral Health Quality of Life (OHQoL) was assessed after 1 and 8 function years.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Totally edentulous for at least four months
- •Sufficient residual bone volume to place two implants of 4 mm in diameter and 9-11 mm in length
排除标准
- •<21 years old
- •General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.
结局指标
主要结局
The effect of surface roughness on long-term crestal bone remodelling.
时间窗: From enrollment until 8 years.
The effect of surface roughness on long-term crestal bone remodelling is evaluated by recording crestal bone loss (mm) on intra-oral periapical radiographs of the implants.
次要结局
- Oral Health Quality of Life (OHQoL)(Assessed after 1 and 8 function years.)
- Peri-implant Health: Probing pocket depth(At one year, 6 years, 8 years and 10 years of follow-up)
- Peri-implant health: Bleeding on probing(At one year, 6 years, 8 years and 10 years of follow-up.)
- Peri-implant Health: Plaque(at one year, 6 years, 8 years and 10 years of follow-up.)