Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Clinical Periodontal Indices
研究概览
简要总结
Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients free from any systemic illness
- •Previously untreated moderate to severe generalised chronic periodontitis.
- •Patients free from adverse reactions to lactose or fermented milk products
- •Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).
排除标准
- •Previous history of antibiotic usage over past 6 months
- •Patients who are eligible for antibiotic usage during the treatment course
- •Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
- •Acute oral lesions or necrotising ulcerative periodontitis
研究组 & 干预措施
Smoker group
30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks
干预措施: Lactobacillus brevis CD2 Lozenges (Drug)
Non-smoker
30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks
干预措施: Lactobacillus brevis CD2 Lozenges (Drug)
结局指标
主要结局
Improvement in Clinical Periodontal Indices
时间窗: 8 weeks
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)
次要结局
- Change in microbiological indices(8 weeks)