Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in implant stability as measured by the Osstell implant stability meter at one year
研究概览
简要总结
At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life.
Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions.
Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient.
The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In need of an auricular, nasal or orbital episthesis
- •Be able to maintain a good personal hygiene
排除标准
- •Contraindications for general anesthesia
- •DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene
- •Poor personal hygiene
- •Pregnancy
- •Acute infection
- •Immunosuppression
- •Compromised by medication
- •Local irradiation >50Gray
研究组 & 干预措施
HAVD implant
干预措施: HAVD-implant (Device)
结局指标
主要结局
Changes in implant stability as measured by the Osstell implant stability meter at one year
时间窗: one year
次要结局
- Clinical ease of use(Directly after implant placement (0))
- redness/irritation of the skin(52 weeks after implant placement)
- Implant survival(52 weeks after implant placement)
- Patient satisfaction as measured by a VAS scoring system(52 weeks after implant placement)
- Quality of life a measured by a VAS scoring system(52 weeks after implant placement)
