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临床试验/NCT02463006
NCT02463006已完成2 期

Comparative Evaluation of Porous and Non Porous Variants of Bioactive Glass in the Treatment of Periodontal Intrabony Defects: A Cone Beam Computed Tomography Analysis

Dr. D. Y. Patil Dental College & Hospital0 个研究点目标入组 10 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
10
主要终点
Change in relative attachment loss

研究概览

简要总结

Till date, no study has been reported in the literature where porous bioactive glass was used for the management of periodontal osseous defects. In this context, the present study is designed to assess the efficacy of the porous variant of bioactive glass and compare with that of nonporous variant using cone beam computed tomography.

详细描述

OBJECTIVES:

  1. To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
  2. To evaluate clinically the periodontal healing with Non Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
  3. To evaluate the radiographic changes in the intra bony defect grafted with Porous variant of Bioactive Glass at baseline and an interval of 6 months.
  4. To evaluate the radiographic changes in the intra bony defect grafted with Non Porous variant of Bioactive Glass at baseline and an interval of 6 months.
  5. To compare clinically soft tissue healing for sites grafted with Porous variant of Bioactive Glass and sites grafted with Non Porous variant of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.
  6. To compare the radiographic changes for sites grafted with Porous variant and sites grafted with Non Porous of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA
  • Age: 18-55 years.
  • Probing Depth >5mm.

排除标准

  • EXCLUSION CRITERIA
  • History of periodontal treatment last six months.
  • Bleeding disorders.
  • Gross oral pathology.

研究组 & 干预措施

porous bone graft group

Experimental

Intervention: Flap surgery procedure with porous bone grafting (Periooglass)

干预措施: Porous variant of Bioactive Glass. (Drug)

Non-porous bone gaft group

Active Comparator

Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels)

干预措施: Non porous variant of Bioactive Glass. (Drug)

结局指标

主要结局

Change in relative attachment loss

时间窗: 6 months

次要结局

  • Change in probing depth(6 months)
  • Change in plaque index(6 months)

研究者

发起方
Dr. D. Y. Patil Dental College & Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

D. Gopalakrishnan

Professor

Dr. D. Y. Patil Dental College & Hospital

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