Clinical and Microbiological Efficacy of Lactobacillus Reuteri as an Adjunctive Therapy to Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes: a Randomized Controlled 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
- 主要终点
- Probing depth
研究概览
简要总结
This study aims to investigate the clinical and microbiological efficacy of Lactobacillus reuteri as an adjunctive therapy to non-surgical periodontal treatment of chronic periodontitis with type 2 diabetes.
详细描述
Periodontitis and diabetes affect the course and outcome of each other. Many studies have shown that for patients with periodontitis, concomitant diabetes can aggravate the destruction of periodontal tissue and accelerate the progression of periodontitis, which is an important risk factor for periodontitis. Affected by diabetes, patients with poor glycemic control have worse periodontal status, and the prognosis of periodontitis treatment is more suspicious. Conversely, periodontitis also affects diabetic status, and periodontitis is associated with dysglycemia, increased insulin resistance, and increased risk of diabetic complications. After periodontal therapy, it is expected to reduce the level of systemic inflammation and ultimately improve glycemic control and overall prognosis of diabetes. However, the treatment of periodontitis with diabetes is still a challenge, and how to improve the prognosis of patients with periodontitis with type 2 diabetes remains to be studied.
BioGaia Prodentis is a probiotic chewable tablet containing Lactobacillus reuteri (combination of L. reuteri DSM 17938 and L. reuteri ATCC 5289). Studies have shown that the use of the probiotics has an additional effect on periodontal therapy. However, in the periodontitis patients with type 2 diabetes, whether the use of this probiotic can improve the effect of periodontal therapy, few relevant research have published.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 35 to 70 years,
- •type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%,
- •generalized periodontitis (Stage III or IV),
- •no less than 15 teeth
排除标准
- •smoking, or quit smoking for less than 5 years;
- •Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.);
- •Received periodontal treatment within 6 months;
- •Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months;
- •Have taken probiotics within 6 months;
- •Prophylactic use of antibiotics is required;
- •Pregnant and lactating women;
结局指标
主要结局
Probing depth
时间窗: change from baseline to day 90
measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15)
Microorganism
时间窗: change from baseline to day 90
measured by 16s rDNA in subgingival plaque and faces
次要结局
- Bleeding of Probing(day 0, 30, 90, 150)
- Fasting Blood Glucose(day 0, 30, 90, 150)
- HbA1c(day 0, 30, 90, 150)
- Gingival index(day 0, 30, 90, 150)
- Gingival Recession(day 0, 30, 90, 150)
- IL-1β、IL-6、TNF-α(day 0, 30, 90, 150)
研究者
Peihui Ding
Associate Professor
The Dental Hospital of Zhejiang University School of Medicine