1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class 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
- 90
- 主要终点
- Change in Bone defect depth
研究概览
简要总结
Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects
详细描述
Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. Then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.
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
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study -
排除标准
- •Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women
研究组 & 干预措施
group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
干预措施: placebo (Drug)
group 2
SRP followed by 1% Alendronate (ALN) gel
干预措施: Alendronate (Drug)
group 3
SRP followed by Aloevera (AV) gel
干预措施: Aloe Vera (Drug)
结局指标
主要结局
Change in Bone defect depth
时间窗: baseline, 6 & 12 months
Assessed in percentage
次要结局
- Change in modified sulcus bleeding index(baseline, 6 & 12 months)
- Change in relative vertical clinical attachment level(baseline, 6 & 12 months)
- Change in pocket probing depth(baseline, 6 & 12 months)
- Change in Plaque index(baseline, 6 & 12 months)
- Change in relative horizontal clinical attachment level(baseline, 6 & 12 months)
研究者
Dr. A R Pradeep
Professor and HOD, Dept of Periodontology
Government Dental College and Research Institute, Bangalore