Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- implant survival
研究概览
简要总结
To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
详细描述
Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •residual bone crest height <5 mm and width ≥6 mm in the planned implant site;
- •healed bone crest (at least 6 months elapsed from tooth loss/extraction);
- •age >18 years;
- •written informed consent given
排除标准
- •absolute medical contraindications to implant surgery;
- •uncontrolled diabetes (HBA1c > 7.5%);
- •treated or under treatment with antiresorptives;
- •irradiated in the head and neck area in the last five years;
- •pregnant or breastfeeding;
- •substance abusers;
- •psychiatric problems or unrealistic expectations;
- •patient not fully able to comply with the study protocol.
- •large sinus cavity (distance >12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest);
- •maxillary sinus conditions contraindicating sinus floor elevation;
- •poor oral hygiene and motivation (Full Mouth Plaque Score >20% and or Full Mouth Bleeding Score >10%)
结局指标
主要结局
implant survival
时间窗: 12 months
implant survival rate after one year of prosthetic loading
次要结局
- vertical bone gain(six months)
- percentual graft shrinkage(six months)
- occurrence of complications(12 months)
研究者
Mr. Claudio Stacchi, DDS, MSc
Claudio Stacchi, DDS, MSc
International Piezosurgery Academy