The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in Clinical Periodontal Indices
研究概览
简要总结
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients on probiotic supplements
- •Patients who have allergy to lactose and fermented milk products
- •Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
- •Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
- •Patient suffering from any systemic illness
- •Patients who are deemed to be un-cooperative
研究组 & 干预措施
Probiotic Arm
L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.
干预措施: Probiotic Arm (Drug)
Placebo Arm
Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).
干预措施: Placebo Arm (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), Bleeding on Probing (BOP)
次要结局
- Improvement in Biochemical Indices(8 weeks)