Collection of Gingival Crevicular Fluid From Periodontitis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Metabolite Associated With Inflammation (Cadaverine)
研究概览
简要总结
To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.
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
- 26 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be aged 18 to 65 years inclusive
- •Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
- •Give written informed consent
- •Be in good general health
- •No known history of allergy to personal care/consumer products or their
- •ingredients, relevant to any ingredients in the test products as determined by the
- •dental/medical professional monitoring the study
排除标准
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Advanced periodontal disease
- •5 or more decayed, untreated dental sites
- •Diseases of the soft or hard oral tissues
- •Orthodontic appliances
- •Abnormal salivary function
- •Use of prescription drugs.
- •Use of antibiotics one (1) month prior to or during this study
- •Use of any over the counter medications other than analgesics
- •Erratic use of vitamin supplements
- •Pregnant or breastfeeding.
- •Participation in another clinical study in the month preceding this study
- •Allergic to common dentifrice ingredients
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
研究组 & 干预措施
A -Control
Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes.
干预措施: Fluoride (Drug)
B
fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)
干预措施: Fluoride, triclosan (Drug)
结局指标
主要结局
Metabolite Associated With Inflammation (Cadaverine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Choline)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Hypoxanthine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Inosine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Isoleucine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Leucine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Lysine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Phenylalanine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Putrescine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Xanthine)
时间窗: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.
次要结局
未报告次要终点