NCT05051839已完成不适用
Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Marginal bone level
研究概览
简要总结
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old.
- •Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
- •Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
- •Healthy ASA type I and II patients.
- •Full-mouth plaque index <20.
排除标准
- •Smokers ≥10 cigarettes/day.
- •Presence of implant-supported restorations adjacent to the study site.
- •Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
- •Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
- •Uncontrolled diabetes.
- •Severe bruxism.
- •Pregnancy.
- •Previous history of radiotherapy.
结局指标
主要结局
Marginal bone level
时间窗: Baseline to 12-months follow-up
Changes in interproximal marginal bone level with standardization of the radiograph
Soft tissue volumetric analysis
时间窗: Baseline to 12-motnhs follow-up
Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit
次要结局
未报告次要终点
研究者
研究点 (2)
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