跳至主要内容
临床试验/NCT02949557
NCT02949557已完成4 期

A Comparative Clinical and Radiographic Evaluation of Demineralized Freeze Dried Bone Allograft (DFDBA) and Xenograft (Cerabone)TM With Decortication in the Treatment of Periodontal Intraosseous Defects

Krishnadevaraya College of Dental Sciences & Hospital0 个研究点目标入组 10 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
10
主要终点
Pocket probing depth

研究概览

简要总结

DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has the potential for osteoinduction due to increased expression of bone morphogenetic protein (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication is performed as a part of guided bone regeneration (GBR) procedure as it enhances the healing process.Therefore a combination of decortication and bone graft when applied in periodontal intrabony defect would enhance the regeneration of periodontium.

详细描述

There have been great strides in the management of periodontal intrabony defects, especially with the use of bone graft materials. It is necessary to choose the most appropriate material and procedure in order to obtain the desired regeneration. Among the bone grafts, Demineralised freezed dried bone allograft (DFDBA) and xenografts have shown good results in the management of intrabony defects. Recently, a novel bovine xenograft i.e., Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication or intramarrow penetration of the bone has shown favourable results in guided bone regeneration procedures. So the goal of the present study was to check the efficacy of decortication with decalcified freeze dried bone allograft (DFDBA) and Cerabone™ bone grafts and to compare the response between the bonegrafts placed following decortication using RVG and CBCT, in intrabony defect.

The combination of decortication with bone grafts i.e., DFDBA and (Cerabone)TM can be an added advantage in the treatment of intrabony defects. To the best of the investigators knowledge no clinical trial reports this combination therapy in scientific literature. There is need for further research in this area.

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 (Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group 25-45 years
  • Moderate periodontitis with pocket probing depth more than 5 mm
  • Bilaterally similiar intrabony defects
  • systemically healthy patients
  • Good compliance

排除标准

  • medically compromised
  • Pregnant and lactating women
  • teeth with mobility and furcation involvement

结局指标

主要结局

Pocket probing depth

时间窗: 9 months

pocket probing depth level measured in mm from gingival margin to base of the pocket

Bone fill

时间窗: 9 months

Bone fill measured in mm in radiographs from alveolar crest to base of the pocket

clinical attachment level

时间窗: 9 months

clinical attachment level measured in mm from cementoenamel junction to the base of the pocket

次要结局

  • Plaque Index (PI)(9 month)
  • Gingival Bleeding Index(9 months)
  • Periodontal disease index(9 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

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