Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: 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
- 主要终点
- amount of bone fill
研究概览
简要总结
ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.
Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.
详细描述
Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.
排除标准
- •patients with systemic diseases like cardiovascular disease
- •diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- •pregnant/lactating females
- •tobacco users
- •alcoholics
- •patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
- •teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
- •Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.
研究组 & 干预措施
SRP plus placebo
SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
干预措施: Placebo Gel (Drug)
SRP plus Atorvastatin
SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
干预措施: Atorvastatin (ATV) (Drug)
结局指标
主要结局
amount of bone fill
时间窗: baseline to 9 months
次要结局
- change in Relative vertical clinical attachment level(baseline to 9 months)
- change in probing depth(baseline to 9 months)
- change in site specific plaque index(baseline to 9 months)
- change in RHCAL (relative horizontal clinical attachment level)(baseline to 9 months)
- change in modified sulcus bleeding index(baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and head, department of periodontics
Government Dental College and Research Institute, Bangalore