Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- bone formation after sinus augmentation
研究概览
简要总结
This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation with concentrated growth factor (CGF) utilizing "dynamic implant valve approach" (DIVA) system.
详细描述
Crestal bone deficiency in the posterior maxilla may present a therapeutic challenge when dental implants are required. Sufficient bone volume is necessary for the long term survival of the implant .
The two most used surgical techniques are the crestal and the lateral window. The latter was first described by Tatum and subsequently, Boyene and James in 1980 . In the original technique, after fracturing the sinus floor, an implant was placed and submerged during the healing phase. The crestal osteotome technique is less invasive and was first described by Summers in 1994 . In this technique, a set of osteotomes is used to prepare the implant site, thereby allowing bone preservation.
Since the sinus augmentation was describes, bone grafts have been the mainstay of treatment. Variable bone grafts, such as autografts, allografts, xenografts, alloplasts, or combinations of different graft materials, have been used widely with similar results . Nonetheless, successful bone augmentation in the maxillary sinus, without bone grafting, have been reported in human and animal studies.
In 2011, Dong-Seok et al described sinus augmentation through a lateral window approach, using a fibrin rich block with concentrated growth factor (CGF). The researchers showed successful new bone formation in the sinus, with a success rate of 98% and no major complications .
Graftless Sinus augmentation relies on bioactive mediators that stimulate cell proliferation, matrix remodeling, and angiogenesis. CGF is one of the latest developments in this field, and is produced by processing blood samples with a special centrifuge device. It contains several mediators - platelet-derived growth factor (PDGF), transforming growth factor-b1 (TGF-b1) and b2 (TGF-b2), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). Because CGF is a dense fibrin matrix, richer in growth factors than other preparations, it has proved to have a better regenerative capacity and versatility .
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No medical history of diseases involving bone metabolism
- •Patients that are treated by a prostodontist
- •Healthy oral cavity and sinuses, and good oral hygiene
- •No bone pathology demonstrated by X-ray
- •Residual sub-antral bone of at least 4mm as demonstrated by computerized tomography (CT)
- •The patient does not participate in another clinical study
- •The patient can read and understand the informed consent
排除标准
- •Medical history of a disease affecting bone metabolism (Diabetes Mellitus, heart disease, renal failure, osteoporosis)
- •Medical treatment that can affect bone metabolism (such as Bisphosphonates)
- •Patients treated with anticoagulants (such as Coumadin, Pradaxa)
- •Personal history of chemotherapy or radiotherapy
- •Patients with maxillary sinus pathology
- •Patients lacking a prostodontic treatment plan
- •Pregnant women
结局指标
主要结局
bone formation after sinus augmentation
时间窗: one year
during postoperative follow-up, bone formation in the maxillary sinus will be assessed by periodic imaging. after one year the investigators expect to see complete implant integration into the bone formed in the maxillary sinus(e.g; the dental implant is completely covered by bone).
次要结局
- Quantification of growth factors released from the CGF matrix in vitro(one year)
研究者
ruth angel dar
Principal Investigator
Western Galilee Hospital-Nahariya