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临床试验/CTRI/2016/11/007428
CTRI/2016/11/007428已完成不适用

Effect of in-situ application of Simvastatin gel in the surgical management of osseous defects in Chronic periodontitis- A clinico-radiographic study.

KLE Society Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年6月4日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Amount of bone fill and percentage of original defect fill in Group 1 was statistically highly significant than Group 2 at the end of 6 and 9 months.

研究概览

简要总结

The present was conducted to evaluate the periodontal tissue response to in-situ gel using simvastatin with carbolopol 934 p (as a vehicle) after surgical debridement of periodontal osseous defects by recording various clinical parameters , Gingival index (GI), Probing pocket depth (PPD) , Plaque index (PI) and Clinical attachment level (CAL ) and Radiographic paramers (Bone fill) at the end of 3 months, 6 months and 9 months.

Results of this studied showed improvement in both clinical and radiographic parameters in both experiment (Group 1) and Control group (Group 2). But, improvement in clinical and Radiographic parameters (Amount of bone fill) in experiment group was statistically highly significant than control group. Results of this study was in accordance with previously conducted study by Pradeep A.R et al - 2010 and Stein D et al 2005. Various studies e.g Mundy et al 1999, Yazawa H et al 2005,Nyan M et al 2007   have also shown the bone anabolic effect of Simvastatin.

This study has concluded that Simvastatin  as a non space occupying host modulatory pharmacologic agent in the form of in-situ gel as an adjunct to mechanical and surgical treatment approaches may be the future potential application in regenerative periodontal therapy. However, more randomized controlled trial with long term followup to be conducted to proclaim the observations of this study.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •Systemically healthy patient diagnosed with generalised chronic periodontitis •Clinical probing pocket depth ≥ 5 mm.
  • •Radiographic evidence of bilateral intrabony defects in mandibular molar region.

排除标准

  • History of antibiotics in last 6 months.
  • History of periodontal therapy in last 6 months.
  • Suspected allergy to statin group.
  • Patients on systemic statin therapy.
  • Patients having Aggressive periodontitis.
  • Current smokers.
  • Immunocompromised patient.
  • Pregnant and lactating females.
  • Patients having any bleeding disorders.
  • Any other contraindication for periodontal surgery.
  • Patients indicated for multiple extractions/undergone multiple extractions.

结局指标

主要结局

Amount of bone fill and percentage of original defect fill in Group 1 was statistically highly significant than Group 2 at the end of 6 and 9 months.

时间窗: 3 months, 6 months and 9 months.

次要结局

  • Both group resulted in significant improvement of both clinical and radiological parameters. There was significant reduction of Gingival Index (GI) , Probing pocket Depth (PPD) and gain in Clinical attachment level (CAL) was observed at the end of 3.6 and 9 months.(3 months, 6 months and 9 months)

研究者

申办方类型
Other [Private Dental college and Hospital]

研究点 (1)

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