CTRI/2024/10/075983已完成3 期
Evaluation of locally delivered alpha 2 macroglobulin for the management of periodontitis
Poulami Chakraborty1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年11月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Clinical attachment loss and Pocket probing depth, Gingival Index, OHI
研究概览
简要总结
- Periodontal disease is a multifactorial chronic inflammatory disease caused by a complex of bacteria interacting with host tissues and cells, which ultimately leads to destruction of the periodontal structures
- Pathogens is involves colonization of periodontal-pathogenic bacteria subgingivally and host response of periodontopathogens which leads to increased production of inflammatory mediators and MMPs.
- Mechanical debridement is gold standard for eradicating periodontopathogens .
- Alpha 2 macroglobulins are large glycoproteins and an integral part of innate immunity. These belong to the family of antiproteases. Alpha -2 macroglobulin inhibits the excess of proteinases released during tissue injury and contributes in protecting body from wide disturbances. When there is imbalance between level of protease inhibitors and level of protease secretion in body it leads to rapid tissue destruction. Locally delivering protease inhibitors at the site of inflammation may enhance pro-resolving responses.
- The aim of this study is to incorporate A2M into hydrogel and apply it as local drug delivery agent in periodontitis management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with atleast 1 site probing depth more than 4mm
- •Patient requiring non surgical treatment were eligible for the study.
排除标准
- •Patients with habits like-smoking, tobacco chewing, having uncontrolled diabetes, hypertension or immunocompromised conditions, pregnant women or lactating mothers, noncompliant or physically challenged people.
结局指标
主要结局
Clinical attachment loss and Pocket probing depth, Gingival Index, OHI
时间窗: Baseline, 30th day, 45th day
次要结局
- MMP-9 gene expression(Baseline, 45th day)
研究者
Poulami Chakraborty
Saveetha dental college and hospital
研究点 (1)
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