跳至主要内容
临床试验/CTRI/2024/03/064054
CTRI/2024/03/064054尚未招募不适用

Comparative evaluation of Simvastatin Gel infused in commercially available bone graft in healing after surgical removal of impacted third molars – Split mouth study.

Damini Goel1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
soft tissue healing and bone height and width of alveolar socket post extraction will be evaluated

研究概览

简要总结

Challenges associated with the extraction of third molars, includes alveolar bone resorption and soft tissue changes. Various techniques have been employed to mitigate these issues, such as alveolar ridge preservation using biocompatible materials. Among these materials, anorganic xenografts have shown promise due to their similarity to human bone and ability to enhance bone formation.

Furthermore, statins, particularly simvastatin, have been extensively studied for their role in bone regeneration. Simvastatin has been shown to increase bone morphogenetic protein-2 (BMP-2) expression, leading to enhanced osteoblastic activity and inhibition of osteoclastic activity, ultimately promoting bone formation while also possessing anti-inflammatory properties.

The study’s goal is to evaluate the combined effect of simvastatin gel and the commercially available xenograft "RegenerOss Synthetic" on healing after the surgical removal of impacted third molars, a novel approach not previously explored in the literature. This evaluation aims to leverage the synergistic potential of simvastatin’s osteogenic and anti-inflammatory properties along with the biocompatibility and scaffold-like structure of RegenerOss Synthetic to optimize bone regeneration and soft tissue healing post-extraction.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient’s age group between 18 to 35 years.
  • 2.Patient indicated for Bilateral impacted third molar extraction with same degree of angulation.
  • 3.Difficulty Index in between 5 and 6 according to Pederson’s scale.
  • 4.Patient willing to undergo the surgery and participate in the study.

排除标准

  • 1.Patients suffering from systemic diseases.
  • 2.Any patient refusing to accept the treatment plan.
  • 3.Patients not willing for follow up.

结局指标

主要结局

soft tissue healing and bone height and width of alveolar socket post extraction will be evaluated

时间窗: after 7th day postoperatively,3 months, and 6 months

次要结局

  • oedema(POD 7)

研究者

发起方
Damini Goel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Damini Goel

Dr.DY Patil Dental College and Hospital

研究点 (1)

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