Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants: An Interventional Study of 10 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Peri-implant tissue reaction
研究概览
简要总结
Patients with craniofacial defects caused by oncologic resection, traumatic events or congenital etiologies suffer from esthetic, functional and psychological problems. Auricular, nasal and orbital defects can be reconstructed with implant retained extra-oral prosthesis. The goal of this study is to evaluate implant survival in temporal, maxillary and orbital bone, and peri-implant tissue reactions using a new implant system developed by BioComp Industries.
详细描述
Protocol:
- Planning The ideal size and location of the implants is based on pre-operative CT or CBCT scan followed by analysis using romexis planning software.
In normal circumstances, without bone limitations, the number and location of the implants will be planned as mentioned below:
- Left auricular region: 2 implants placed on position 4h and 1h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 1h30, 3h and 4h30. The inter implant distance is 20mm.
- Right auricular region: 2 implants placed on position 8h and 10h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 10h30, 9h and 7h30. The inter implant distance is 20mm.
- Nasal region: 2 implants placed in the lateral parts of the piriform aperture of the maxilla, as far away from the spina nasalis anterior as possible. If necessary a third implant will be placed in the glabella.
- Left orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 1h, 2h, 3h en 5h.
- Right orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 11h, 10h, 9h en 7h.
If for some reason there is insufficient bone in the above mentioned areas, the position of the implants will be minimally adjusted in order to secure good osseointegration. Neuronavigation will be used for cases with limited bone volume. 2. Flap design During surgery the first step is the creation of a skin flap or resection of a tumor, exposing the area for implantation. 3. Implantation The implantation protocol as described by BioComp Industries will be used. Each drilling procedure is executed by 1800-2000rpm with water cooling.
- Defining the implant location with the 2,45mm diameter round bur.
- Preparation of the implant site with the implant drills, length and diameter of the drill is dependent on the length and diameter of the implant. Drilling protocol will always start with the smallest and shortest drill and gradually expanded, corresponding to the size of the implants.
- Placement of the implant without water cooling at 15rpm and maximal torque of 52Ncm. If necessary the implant will be inserted manually.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with auricular, nasal, orbital defects caused by congenital, traumatic, oncologic or infectious etiologies
- •Adults (>18yr)
排除标准
- •Implant placement for bone anchored hearing aid (BAHA)
- •Implant placement for oral rehabilitation
结局指标
主要结局
Peri-implant tissue reaction
时间窗: 1 year
Measurement of peri-implant pockets and soft tissue according to Holgers criteria
Implant survival
时间窗: 1 year
Implant stability measurement with Osstell IDX system
次要结局
- Bone level(1-2 weeks post-operative, 1 year)