Adjuvant use of Probiotics in the management of Periodontitis in Diabetics: A Randomized, Double-blind Clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- to reduce subgingival microbiota
研究概览
简要总结
This is a randomized double-blind parallel-group placebo-controlled clinical trial which will be conducted among subjects with Periodontitis with or without Diabetes. This study will compare the efficacy of Probiotics lactobacillus fermentum andBifidobacterium longum in Diabetic subjects with Periodontitis. study population is to be divided in to two groups.
A. Periodontitis subjects with Diabetes
B. Periodontitis subjects without Diabetes
Each group is further divided in to 3 sub-groups, (A1, A2, A3; B1, B2, B3) two test groups and one control group. Subjects will be allotted to different groups based on Computer generated Randomization table
In this study, freeze dried Probiotic powder will be supplied to patients. They will be asked to use probiotic powder for around 4 weeks.
Among three sub groups, participants in first group (A1, B1) are served with Lactobacillus Probiotic, second group (A2, B2) with Bifidobacterium Probiotic, and the third group (A3, B3) i.e. controls with Sorbitol (Placebo)
Subjects will be demonstrated to mix 2 grams of Freeze-Dried probiotic powder with few drops of water to make it in to thick paste and will be instructed to apply it all over the gums and teeth, daily in the morning after their breakfast and before going to bed for around 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Periodontal pocket depth ≥ 5mm Type II Diabetic subjects with glycated haemoglobin range between 7% –10 %.
排除标准
- •Smokers Pregnant and lactating mothers People with a compromised immune system Antibiotic therapy during the previous 6 months Systemic diseases other than Diabetes Subjects taking medications that could interfere with gingival tissue responses.
结局指标
主要结局
to reduce subgingival microbiota
时间窗: baseline,30days
次要结局
- to reduce periodontal pocket depth, plaque,gingival bleeding and inflammation(baseline,30days,45days,90days)