1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Defect depth reduction (%)
研究概览
简要总结
The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.
详细描述
Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP).
Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study.
- •A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years
排除标准
- •Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study
研究组 & 干预措施
Placebo Group
Oral prophylaxis followed by placebo gel placement in intrabony defects
干预措施: SRP plus placebo gel (Drug)
Rosuvastatin Group
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
干预措施: SRP plus Rosuvastatin gel (Drug)
结局指标
主要结局
Defect depth reduction (%)
时间窗: Change from baseline to 9 months
assessed in percentage
次要结局
- probing depth (mm)(Change from baseline to 9 months)
- clinical attachment level (mm)(Change from baseline to 9 months)
- modified sulcus bleeding index(Change from baseline to 9 months)
- Plaque Index(Change from baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and HOD, Dept of Periodontology
Government Dental College and Research Institute, Bangalore