The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- HbA1c Levels in Blood
研究概览
简要总结
Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of >200mg/dl.
- •Minimum of 16 teeth
- •Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6 teeth
排除标准
- •Any condition requiring antibiotic cover for dental treatment
- •Other serious illness
研究组 & 干预措施
Total toothpaste
Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.
干预措施: Triclosan/copolymer/fluoride (Drug)
Fluoride mouthrinse
Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
干预措施: Fluoride (Drug)
结局指标
主要结局
HbA1c Levels in Blood
时间窗: 12 months
Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.
C-Peptide
时间窗: 12 months
C-Peptide levels in blood indicate whether or not a person is producing insulin
TNF-α (Tumor Necrosis Factor - Alpha)
时间窗: 12 months
Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.
IL-6 (Interleukin - 6)
时间窗: 12 months
Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)
High Sensitivity CRP (C-Reactive Protein)
时间窗: 12 months
CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.
次要结局
未报告次要终点