Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Improvement in periodontal indices
研究概览
简要总结
Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.
A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.
The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes
- •Patients in the age group of 25-60 years
- •Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
- •The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
- •Subjects in good general health
排除标准
- •No antibiotic therapy in the past 2 months
- •Medically compromised patients
- •Subjects who are pregnant/ lactating
- •Smokers and/or alcoholics.
- •Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
研究组 & 干预措施
Probiotic (Inersan) Arm
Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
干预措施: Probiotic (Inersan) (Drug)
Placebo Arm
Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in periodontal indices
时间窗: 6 weeks, 12 weeks
Improvement in Periodontal indices, namely, plaque index \[PI\], Gingival index \[GI\], Gingival bleeding index \[GBI\], probing pocket depth \[PPD\] and clinical attachment levels \[CAL\] in both groups
次要结局
- Microbiological indices(6 weeks, 12 weeks)