Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Amount of bone gain (height and width in mm)
研究概览
简要总结
Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.
CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.
Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio
- 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
- 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with atrophied anterior maxillary ridge area.
- •Age: 18 years and older.
- •Both sexes.
- •No intraoral soft and hard tissue pathology.
- •No systemic condition that contraindicate bone augmentation
排除标准
- •• Heavy smokers more than 20 cigarettes per day.(32)
- •Patients with systemic disease that may affect normal healing.
- •Psychiatric problems.
- •Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
- •Pregnant or nursing women.
- •Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
- •Patient with previous history of radiotherapy.
研究组 & 干预措施
intervention
using a bio-oss bovine bone alone
干预措施: Geistlich Bio-Oss® bovine bone alone (Other)
control
using a bio-oss bovine bone with autogenous bone ratio 1:1
干预措施: Geistlich Bio-Oss® bovine bone alone (Other)
结局指标
主要结局
Amount of bone gain (height and width in mm)
时间窗: 6 months
will be measured using linear measurements from CBCT
次要结局
- a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)(6 months)
研究者
Sherif osama hegazy
principal investigator
Cairo University