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临床试验/NCT05719181
NCT05719181招募中1 期

Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023

University of Baghdad2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
32
试验地点
2
主要终点
Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

研究概览

简要总结

Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

详细描述

The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients have good oral hygiene.
  • Systemic healthy individuals ,Age more than18 years.
  • Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol).
  • Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant.

排除标准

  • Presence of systemic diseases preventing implantation.
  • Previous implantation or augmentation of the same region.
  • The need for additional bone augmentation procedures (such as maxillary sinus augmentation)
  • Partial or total edentulous ridge associated with a severe knife-edge ridge .
  • Acute infection or any pathological lesion a the implant site.
  • Allergy to one of the materials to be used during operation.
  • Pregnancy.
  • Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.

结局指标

主要结局

Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

时间窗: At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.

The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.

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

Abdullah Ali Abbas

master student

University of Baghdad

研究点 (2)

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