NCT00762450已完成3 期
Effect on Bacterial Glycolytic Acid Formation on Plaque
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- ph of Dental Plaque After Sucrose Challenge
研究概览
简要总结
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 72 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary dentition is preferentially natural.
- •Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
- •Natural mandibular front teeth and first premolars (4-4) are retained.
- •Second mandibular molars are ideally present to serve as abutment teeth.
- •Mandibular restorations and/or reconstructions must be in clinically good condition.
- •Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
- •Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
- •Willingness to give their informed consent and comply with the protocol.
- •No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
排除标准
- •Current participation in other dental clinical trials.
- •Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
- •Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
- •Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
- •Subjects taking drugs known to currently affect salivary flow.
- •Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min.
- •Women who are pregnant or breastfeeding
- •History of allergy to common dentifrice ingredients
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- •Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
- •Medical condition which requires premedication prior to dental procedures/visits
- •History of allergy to amino acids
研究组 & 干预措施
A- Positive Control
Active Comparator
fluoride/triclosan/copolymer toothpaste
干预措施: Triclosan, Fluoride (Drug)
B - Silica control
Placebo Comparator
fluoride only toothpaste
干预措施: fluoride (Drug)
C- Experimental product
Experimental
fluoride/triclosan/amino acid toothpaste
干预措施: Fluoride, triclosan, amino acid (Drug)
结局指标
主要结局
ph of Dental Plaque After Sucrose Challenge
时间窗: 1 week
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
次要结局
未报告次要终点
研究者
研究点 (1)
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