The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Bone defect fill
研究概览
简要总结
Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.
Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.
Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P<0.05) was considered significant.
详细描述
Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected
排除标准
- •systemic disease
- •pregnancy or breastfeeding
- •allergy drug used
- •not willing to consent to participate in the study
- •7-Trismus 8-The type of disease periodontal (Aggressive)
- •History of periodontal treatment in the previous 6 months 10-orthodontic treatment
研究组 & 干预措施
levostatin gel
levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe
干预措施: Lovastatin gel (Drug)
placebo gel
placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe
干预措施: Placebo (Drug)
结局指标
主要结局
Bone defect fill
时间窗: Three months
radiographic analysis for bone defect
次要结局
未报告次要终点
研究者
Amirhossein Farahmand
The effect of lovastatin gel in the treatment of chronic periodontitis a randomized controlled trial with split-mouth
Islamic Azad University, Tehran