ChiCTR2000040347尚未招募不适用
The effects of probiotic supplementation in chronic periodontal patients with Type 2 diabetes – a randomised controlled trial
Health and Medical Research Fund (Ref:07182086)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- probing pocket depth
研究概览
简要总结
To determine whether dental patients diagnosed with chronic periodontal disease with Type 2 diabetes find increased added benefit in periodontal outcomes from a Prodentis adjunct and non-surgical PDT compared to PDT alone, which may provide greater efficacy in periodontal outcome.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 35 至 75（—）
- 性别
- All
入选标准
- •Aged 35-75 years old diagnosed with chronic periodontal disease and Type 2 diabetes
- •willing to participate in a 1-yr study;
- •without periodontal treatment in the last 6 months;
- •Type 2 diabetes > 6 months and under physicians care for Type 2 diabetes;
- •non-smoking; no antibiotics or NSAID use within the last 3 months.
排除标准
- •probiotic supplementation; smoking; malignancy diagnosis; immunosuppressive medication; systemic inflammatory disease; pregnancy; limited life expectancy.
研究组 & 干预措施
Group 2
a Prodentis adjunct and non-surgical PDT
Group 1
PDT alone
结局指标
主要结局
probing pocket depth
次要结局
- clinical attachment loss
- full mouth plaque score
- full mouth bleeding score
- Body Mass Index
研究者
研究点 (1)
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