To Assess the Bone Regeneration in extraction sockets using Simvastatin in comparison to Rosuvastatin : a Randomized Control Trial
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
DR Chinmoy sanjay punalekar
KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010
