Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- M3 Health
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
研究概览
简要总结
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical parameters:
- •Presence or absence of pain or tenderness
- •Presence or absence of suppuration or exudation
- •Presence or absence of mobility
- •Prosthetic parameters
- •Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).
- •Radiographic Parameters
- •Presence or absence of peri-implant radiolucidity.
- •maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.
- •Distance between the shoulder of the implant and the first visible bone contact (in mm).
- •Presence or absence of technical complications such as fracture or loss of porcelain structures.
- •Success Parameters
- •Absence of pain or tenderness.
- •Absence of suppuration or exudation.
- •Clinical absence of implant mobility.
- •Absence of peri-implant radiolucency.
- •Minor loss of up to 1.5mm in the first year of function.
- •Absence of mechanical or technical complications in the dental implant and in the prosthesis to the dental implants installed in an area grafted.
排除标准
- 未提供
研究组 & 干预措施
Dental Implants installed in an grafted area (sinus lifting)
Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - sinus lifting.
干预措施: Dental Implants installed in an grafted area (sinus lifting) (Procedure)
Dental Implants installed in an grafted area (ridge augmentation)
Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - ridge augmentation.
干预措施: Dental Implants installed in an grafted area (ridge augmentation) (Procedure)
Dental Implants installed in an grafted area (extraction sites)
Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - extraction sites (socket preservation or dental implant preparation/placement).
干预措施: Dental Implants installed in an grafted area (extraction sites) (Procedure)
结局指标
主要结局
The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
时间窗: 12 months
The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)
次要结局
- The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)(12 months)
- Rate of bone loss(12 months)