Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Soft tissue evaluation:
研究概览
简要总结
The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient aged 18 - 80 yrs.
- •Implants treatment planned for single crown rehabilitation.
- •Submerged implant placement.
- •Patients willing to participate in a twelve month study.
- •Up to 2 implants per patient will be allowed.
排除标准
- •Active periodontal disease.
- •Systemic condition and medication that may affect soft and hard tissue healing.
- •Pregnancy or intention to become pregnant in the next twelve months.
- •Parafunctional occlusal scheme and habits.
研究组 & 干预措施
Group A
23 implants using SPK Abutments
干预措施: spk (Procedure)
Group B
implants using CPK Abutments
干预措施: CPK Abutments (Procedure)
结局指标
主要结局
Soft tissue evaluation:
时间窗: 12 month
Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery.
Radiographic evaluation:
时间窗: 12 month post surgery
Bite wing radiographs will be used to assess changes in radiographic bone height. Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery.
次要结局
未报告次要终点