Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Histological analysis
研究概览
简要总结
To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.
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
- Single (Outcomes Assessor)
盲法说明
Clinical examiners, study surgeons, and subjects will not be blinded. Analysis of histomorphometric, histologic, and volumetric data will be completed by an external lab and will not be aware of what group the subjects were in.
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
- •Patients of Tufts School of Dental Medicine (TUSDM)
- •Two stage sinus augmentations with <5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
- •Full maxillary edentulism or Kennedy class I or III
- •18 to 100 year old
排除标准
- •Adults unable to consent (cognitively impaired adults)
- •Those who self-report as pregnant or breastfeeding
- •Wards of the state
- •Non-Viable neonates
- •Neonates of uncertain viability
- •< 18 years of age
- •Refusal to participate
- •Prior medical condition causing complications in bone metabolism
- •Osteoporosis
- •History of/or current chemotherapy
- •History of/or current head and neck radiation
- •Current heavy smoking > 10 cigarettes/day
- •Self-reported pregnancy or lactation
- •Previous history of sinus elevation procedure
- •Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
- •Absence of autogenous donor site
研究组 & 干预措施
Xenograft - Autogenous 1:4
Sinus grafted with a ratio of Xenograft - Autogenous 1:4
干预措施: Sinus Lift augmentation (Procedure)
Xenograft - Autogenous 1:4
Sinus grafted with a ratio of Xenograft - Autogenous 1:4
干预措施: Cone-beam computed tomography systems (CBCT) (Device)
Xenograft alone
Sinus grafted with Xenograft only
干预措施: Sinus Lift augmentation (Procedure)
Xenograft alone
Sinus grafted with Xenograft only
干预措施: Cone-beam computed tomography systems (CBCT) (Device)
结局指标
主要结局
Histological analysis
时间窗: 4 months from surgery
Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate
次要结局
- Radiographic bone height gain at 4 months(4 months post sinus augmentation)
- Volumetric bone analysis 4 months post sinus augmentation(4 months from surgery)