The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- HbA1c Levels in Blood
研究概览
简要总结
To test effectiveness of dentifrice in maintaining periodontal health.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months
- •Aged 18 to 75 years
- •Able to give informed consent
- •Minimum of 12 teeth
- •Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6 teeth
排除标准
- •Pregnancy
- •Gross dental caries
- •Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation)
- •Anticoagulant therapy (excluding asprin)
研究组 & 干预措施
A
干预措施: Triclosan, Fluoride (Drug)
B
干预措施: Fluoride (Drug)
结局指标
主要结局
HbA1c Levels in Blood
时间窗: 12 months
Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
C-Peptide
时间窗: 12 months
C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Gingivitis Score (GI)
时间窗: 12 months
Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
P. Gingivalis
时间窗: 12 months
Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.
次要结局
未报告次要终点