A comparative evaluation of osseous regeneration in the surgical extraction socket of mandibular third molars using a semisolid simvastatin formulation vs PRF (Platelet Rich Fibrin) - A Split Mouth Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the bone height, bone volume, bone mineral density and trabecular pattern in the empty surgical extraction socket where simvastatin/PRF (Platelet Rich Fibrin) is placed, via CBCT analysis.
研究概览
简要总结
This is a randomized controlled trial (flip of coin), interventional split mouth study to compare the quality and quantity of osseous regenerate in the bony surgical extraction sockets of bilaterally impacted third molars, using Simvastatin Semi-solid gel formulation versus PRF. The primary objective of the study is to determine bone mineral density, bone volume, bone height and trabecular pattern of regenerate, via CBCT analysis.
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, Investigator and Outcome Assessor 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
- •Surgical site should be free of infection.
- •Patient requiring extraction bilaterally of impacted mandibular third molars.
- •The site should be where primary wound closure can be achieved.
排除标准
- •Patient having connective tissue/bleeding disorders.
- •Patient who have undergone radiation/chemotherapy to head and neck region.
- •Patients allergic to drug simvastatin.
- •Patient having uncontrolled diseases of systemic nature.
- •Patients with fibro-osseous diseases of bone.
- •Any pathology associated with apical region of mandibular third molar.
- •Patients on immuno-supressants and/or on anticoagulants.
结局指标
主要结局
To compare the bone height, bone volume, bone mineral density and trabecular pattern in the empty surgical extraction socket where simvastatin/PRF (Platelet Rich Fibrin) is placed, via CBCT analysis.
时间窗: CBCT analysis to be done- | of bony socket before placement of Simvastatin/PRF immediately after surgical extraction of third molars (baseline). | 6th month post-operatively.
次要结局
- To estimate pain at follow-up.(1st week, 3rd week, 3rd month and at 6th month.)
- To measure swelling at follow-up.(1st week, 3rd week, 3rd month and at 6th month.)
- To assess the probing depth distal to the second molar.(1st week, 3rd week, 3rd month and at 6th month.)
- To observe for trismus.(1st week, 3rd week, 3rd month and at 6th month.)