Clinical and Microbiological Evaluation of Probiotics as an Adjunct to Initial Periodontal Treatment in Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Probing Depth
研究概览
简要总结
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
详细描述
The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.
Thirty chronic periodontitis patients were randomized into 2 groups. As adjunctive to MPT, Group 1 consumed 2×108 CFU/day of Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt while Group 2 natural yoghurt once daily for 28 days. Subgingival plaque samples were obtained from 2 periodontal sites with probing pocket depth (PPD) of 4≤PPD<7 mm via paper-points at baseline, 28th day, 3rd month. Samples were cultured to evaluate total viable count (TVC), the proportions of obligate anaerobes (OA) and Bifidobacterium species (B) (TVC%). The full-mouth recorded clinical parameters were plaque index, gingival index, PPD, bleeding on probing, and clinical attachment level.
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
- Double (Participant, Care Provider)
盲法说明
Individuals and doctor were blinded to the study groups allocation. Before statistical analysis, the blind study coordinator broke the code to allocate the indivuals to the groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chronic periodontitis patients with radiographically detected horizontal bone loss
- •the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
- •previously untreated periodontitis, systemically healthy
排除标准
- •Systemic diseases
- •Antibiotics and anti-inflammatory drugs within 3 months before the study
- •Untreated caries lesions or local retention factors
- •Allergic reactions to lactose or fermented milk products
- •Previous probiotic supplements in diet
- •Pregnancy
研究组 & 干预措施
Natural yoghurt
SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
干预措施: probiotic or natural yoghurt (Dietary Supplement)
Natural yoghurt
SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)
干预措施: SRP (Procedure)
Probiotic yoghurt
SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)
干预措施: probiotic or natural yoghurt (Dietary Supplement)
Probiotic yoghurt
SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)
干预措施: SRP (Procedure)
结局指标
主要结局
Probing Depth
时间窗: 28 days
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
次要结局
- Gingival Index(28 days)
- Plaque Index(28 days)
- Clinical attachment level(28 days)
- microbiological parameters(28 days)
- Bleeding on probing(28 days)