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临床试验/NCT04372420
NCT04372420已完成不适用

Recombinant Human Bone Morphogenetic Protein-2 In Absorbable Sponge Vs Platelet Rich Fibrin (PRF) In Grade Ii Furcation Defects - A Randomized Controlled Trial

SVS Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年12月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
BONE FILL

研究概览

简要总结

The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

详细描述

44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using ImageJ® software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to PRF. From this trial conducted over a period of 6 months, the unique properties associated with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material for Grade II furcation defects.

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, Outcomes Assessor)

盲法说明

participant and outcome assessor are masked from the study

入排标准

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

入选标准

  • Systemically healthy male and female patients of age group 20-55 yrs
  • grade II furcation involvement and probing pocket depth of ≥5mm

排除标准

  • Medically compromised patients
  • subjects who underwent radiotherapy or chemotherapy in the past 12 months
  • patients having uncontrolled periodontal disease and
  • subjects smoking ≥10 cigarettes per day were excluded

研究组 & 干预措施

RhBMP-2

Active Comparator

RhBMP-2 belongs to TGF-β super family with osteoinductive property which is capable of promoting bone formation

干预措施: RhBMP-2 absorbable sponge in grade II furcation (Drug)

PLATELET RICH FIBRIN

Placebo Comparator

Platelet rich fibrin(PRF) is a healing biomaterial with a great potential for bone and soft tissue regeneration, without any inflammatory reactions

干预措施: PLATELET RICH FIBRIN in grade II furcation (Procedure)

结局指标

主要结局

BONE FILL

时间窗: 6 MONTHS

The evaluation of bone fill was performed after 6 months by using ImageJ® software.

次要结局

未报告次要终点

研究者

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

Dr R Viswa Chandra

Principal Investigator

SVS Institute of Dental Sciences

研究点 (1)

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