NCT02168543已完成2 期
Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
Government Dental College and Research Institute, Bangalore0 个研究点目标入组 46 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Change from baseline plaque scores at 2 month and 6 month
研究概览
简要总结
- Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients
- Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered ALN as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
- •No history of periodontal therapy in preceding last 6 months
- •No use of antibiotics in the preceding 6 months
排除标准
- •Subjects with known systemic disease
- •Known or suspected allergy to the ALN/bisphosphonate group
- •Those on systemic ALN/bisphosphonate therapy
- •Subjects with aggressive periodontitis,
- •Use of smokeless tobacco in any form,
- •Alcoholics
- •Immunocompromised subjects
- •Pregnant or lactating females
研究组 & 干预措施
Alendronate
Experimental
1% Alendronate gel once in periodontal pocket (Gums)
干预措施: Alendronate (Drug)
Placebo
Placebo Comparator
Placebo gel once in periodontal pocket (Gums)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline plaque scores at 2 month and 6 month
时间窗: At baseline, 2nd month and 6th month
Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline gingival scores at 2 month and 6 month
时间窗: At baseline, 2nd month and 6th month
Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
次要结局
- Change from baseline Probing depth at 2 month and 6 month(At baseline, 2nd month and 6th month)
- Change from baseline Periodontal attachment level at 2 month and 6 month(At baseline, 2nd month and 6th month)
- Change from baseline intrabony defect depth at 6 month(At baseline and 6th month)
研究者
Dr. Anuj Sharma
Anuj Sharma
Government Dental College and Research Institute, Bangalore
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