A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
研究概览
简要总结
The aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (PGRM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
- •Plaque sample acidogenicity in the pH range 5.0 to 5.7 at Visit.
排除标准
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Women who are breast-feeding.
- •Currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (Visit 2). A participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes).
- •Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala.
- •Current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject.
- •Restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
- •Partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
- •Recent history (within the last year) of alcohol or other substance abuse.
研究组 & 干预措施
Test zinc-IPMP toothpaste
Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water
干预措施: Test zinc-IPMP toothpaste (Other)
Test zinc non- IPMP toothpaste
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
干预措施: Test zinc non- IPMP toothpaste (Other)
Positive control Toothpaste
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
干预措施: Positive control (Other)
SLS Negative Control
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
干预措施: SLS negative control (Other)
non-SLS negative control
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
干预措施: non-SLS negative control (Other)
结局指标
主要结局
Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
时间窗: Baseline up to 90 minutes (min)
AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.
次要结局
- AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control(Baseline up to 90 min)
- AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control(Baseline up to 90 min)
- AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control(Baseline up to 90 min)