Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- marginal bone loss
研究概览
简要总结
The Aim of this study randomized prospective clinical trial is to examine and compare periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading using the alpha Bio Neo standard diameter implants with conical abutment.
详细描述
Peri-implant marginal bone level is one of the most important references criteria to monitor peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding year, is an acceptable criterion to determine implant success.
Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar bone loss and dental implant failure.
Platform switching, also known as platform shifting, is whenever an abutment is used that is smaller in diameter than the implant platform. Platform switching can help prevent crestal bone loss.
The hypothesis of the present study is that the use of conical abutment might reduce marginal bone loss around dental implants in both smokers and non-smokers alike.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 - 85 years.
- •Written informed consent.
- •In need for a dental implant Adequate alveolar bone Intended to be restored with individual crowns.
- •Heavy smokers (20 Cig/d > 5years) or non / former smokers (> 5 years since cessation).
排除标准
- •Active periodontal disease.
- •Systemic condition and medication that may affect soft and hard tissue.
- •healing Parafunctional occlusal scheme and habits.
- •Pregnancy or intention to become pregnant in the following twelve months.
- •Patient not willing or able to meet the study schedule.
- •Patient in need for simultaneous bone graft or GBR using a membrane barrier.
结局指标
主要结局
marginal bone loss
时间窗: 6 months and 18 months after implantation.
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
次要结局
- Implants probing depth (IPD)(4 months, 6 months and 16 months after implantation)
- Bleeding on probing(4 months, 6 months and 16 months after implantation)
- Labial gingival recession(4 months, 6 months and 16 months after implantation)