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临床试验/NCT03628157
NCT03628157Unknown2 期

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

Cairo University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月最近更新:
适应症
干预措施

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

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

Experimental

using a bio-oss bovine bone alone

干预措施: Geistlich Bio-Oss® bovine bone alone (Other)

control

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherif osama hegazy

principal investigator

Cairo University

研究点 (2)

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