Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Crestal bone loss (mm)
研究概览
简要总结
24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single missing maxillary premolar
- •Occlusal stability
- •Good oral hygiene
- •Good general health
排除标准
- •Oral mucosa pathology
- •Dental caries
- •Active periodontitis (non-treated)
- •Systemic diseases and conditions that affect healing or immune capacity
研究组 & 干预措施
Tissue-level
Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.
干预措施: Zirconia dental implants (Device)
Bone-level
Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.
干预措施: Zirconia dental implants (Device)
结局指标
主要结局
Crestal bone loss (mm)
时间窗: baseline, 1-year, 3-years, 5 years
Loss of marginal bone in mm
次要结局
- Volumetric tissue change(1-year, 3-years, 5 years)
- Probing depth (mm)(baseline, 1-year, 3-years, 5 years)
- Bleeding on probing (BOP)(baseline, 1-year, 3-years, 5 years)