Effect of Probiotic Lozenges as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis Patients: A Randomized Double Blind Placebo Controlled Clinical and Biochemical Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement in Periodontal Clinical indices
研究概览
简要总结
Periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.It comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. In the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain.
Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to Scaling and Root Planing, on clinical and biochemical parameters.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject of both sexes
- •Age group of 25-65 years
- •Subjects with generalized moderate to severe chronic periodontitis
- •Signed informed Consent
排除标准
- •Any known history of systemic diseases
- •Patients already on anti-inflammatory drugs or antibiotics
- •Patients allergic to any material used in the study
- •Pregnant and lactating women
- •Periodontal therapy in past 6 months
- •Current smoker or smoker in the past
研究组 & 干预措施
Probiotic (Inersan) Arm
Inersan Lozenges (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). 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 (4 Lozenges per day; 1 lozenge in morning,1 lozenge in the afternoon and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Periodontal Clinical indices
时间窗: 6 weeks
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Plaque Index (PI), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
次要结局
- Improvement in biochemical indices(6 weeks)