Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold (Ossix Volumax) Versus Freeze-dried Bone Allograft (FDBA) With Collagen Membrane
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in socket width mm
研究概览
简要总结
The aim of the current study is to compare lateral bone augmentation using the current gold standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone material.
详细描述
One of the major problems in implant therapy is the need to regenerate bone after its resorption because of periodontal disease, traumatic extraction or surgical removal associated with treatment of invasive lesions.
Ossix Volumax is a novel volume maintaining collagen scaffold designed for bone augmentation in the atrophic ridge. It is 1-2 mm in thickness and undergoes mineralization progressing into ossification.
Thirty subjects requiring lateral bone augmentation of the maxilla or the mandible will be recruited study: Of these, twenty will be recruited and treated at the School of Dental Medicine, Harvard University, Boston, USA and ten (10) at the School of Graduate Dentistry, Rambam health care campus, Haifa, Israel.
Hypothesis
The use of Ossix Volumax as a stand-alone augmentation material will results similar increase in the ridge width and volume compared to FDBA and barrier membrane when coupled together.
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 (Participant)
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
- 是
入选标准
- •Patients age 18 to 85 years of age.
- •Alveolar ridge atrophy (<5 mm) in the horizontal dimension requiring bone augmentation.
- •Implant therapy is scheduled for this site.
- •Willing to participate in the study and follow all the post-op visits.
排除标准
- •Systemic condition requiring prophylactic antibiotics.
- •The Introduction( I.V.) use of medication related osteonecrosis of the jaw ( MRONJ) or the use of such medication Per Os (P.O.) for five or more years, patients with at least three month drug holiday with a C-terminal cross-linking telopeptide (CTX) > 150 pg/ml are eligible.
- •The use of medication known to impair healing (clinician desecration).
- •Unable to place implant for whatever reason.
研究组 & 干预措施
Ossix Volumax
lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax)
干预措施: Ossix Volumax (Device)
FDBA with collagen membrane
lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane
干预措施: FDBA with collagen membrane (Device)
结局指标
主要结局
Changes in socket width mm
时间窗: baseline( prior to augmentation) and 9 months (implant placement)
Clinical measurement of the ridge width as -2, -5 \& -8 mm from crest at the Region of interest (ROI) using a caliper
次要结局
- Changes in Ridge height mm(baseline( prior to augmentation) and 9 months (implant placement))