Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Bleeding on probing
研究概览
简要总结
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
详细描述
Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation.
Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No or minimal clinical signs of gingival inflammation
- •Gingival Index ≤ 1
- •No probing depth (Probing depth > 3 mm)
- •No approximal attachment loss > 2 mm
- •Non smokers
排除标准
- •Systemic diseases
- •Antibiotics and anti-inflammatory drugs within 3 months before the study
- •Untreated caries lesions or local retention factors
- •Mouth-breathing
- •Allergies
- •Previous probiotic supplements in diet
研究组 & 干预措施
Probiotic Yoghurt
Probiotic yoghurt consumption
干预措施: Probiotic Yoghurt (Dietary Supplement)
Natural Yoghurt
Natural yoghurt consumption
干预措施: Natural Yoghurt (Dietary Supplement)
结局指标
主要结局
Bleeding on probing
时间窗: 33 days after yoghurt consumption
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
次要结局
- Gingival Index(33 days after yoghurt consumption)
- Plaque Index(33 days after yoghurt consumption)