跳至主要内容
临床试验/CTRI/2025/04/084299
CTRI/2025/04/084299已完成2/3 期

To Assess the Bone Regeneration in extraction sockets using Simvastatin in comparison to Rosuvastatin : a Randomized Control Trial

Dr. Chinmoy punalekar1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年4月17日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Bone density, Bone width , Bone height measured on the cone beam computed tomography of the extracted socket

研究概览

简要总结

·        Tooth loss affects the quality of life as it leads to ineffective mastication ,altered speech, concern about the appearance ,  loss of self confidence.·        Partial or complete edentulism leads to bone resorption making rehabilitation difficult.·        Following tooth extraction ,Several  Interventions that involve autografts, allografts, xenografts, guided bone regeneration (GBR) and growth factors have been used with varying degrees of success in an effort to maintain the anatomical dimensions of the alveolus before implantation.·        Although autograft is considered gold standard there is risk of donor site morbidity , pain , infection , scarring , etc. ·        Commonly used  xenograft have higher risk of the immunological reaction and  infection, etc.·        There is a constant search for the ideal graft material ·        Mundy G et al (1999) examined several compounds and found that Statin drugs like simvastatin used for lowering serum cholesterol increased the expression of bone morphogenetic protein-2 (BMP-2) gene in bone cells which leads to bone formation.·        Rosuvastatin is a 2nd generation , hydrophilic stain which has demonstrated bone regeneration properties in furcation defects: hence the aim of this  study is to assess efficacy of Simvastatin and Rosuvastatin in regeneration of the bone after the extraction of the teeth.

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 Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

  • Patients between 18 to 65 years requiring tooth extraction Patients willing to give informed and written consent.

排除标准

  • Patients who are medically compromised • Patients allergic to drug.

结局指标

主要结局

Bone density, Bone width , Bone height measured on the cone beam computed tomography of the extracted socket

时间窗: 3 months

次要结局

  • post operative pain using visual analog score scale.(7 days)

研究者

发起方
Dr. Chinmoy punalekar
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

DR Chinmoy sanjay punalekar

KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010

研究点 (1)

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