In-house Study to Determine the Effect of Two Zinc-containing Toothpaste Formulations on Viability of Bacteria in Saliva
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique
研究概览
简要总结
This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.
详细描述
This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Personnel: GSKCH permanent and contract/contingency workers.
- •Consent: Demonstrated understanding of the study and was willing to participate and had received a signed and dated copy of the informed consent form.
- •Compliance: Understood, was willing and able and complied with all study procedures and restrictions.
- •General Health: Good general health
- •Oral Health: Good oral health
- •Salivary Flow Rate: Had a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2milliliter per minute (ml/min); stimulated whole saliva flow rate ≥ 0.8ml/min)
排除标准
- •Study personnel: Members of the clinical study staff.
- •Pregnancy: Pregnant Women
- •Breast-feeding: Women who were breast-feeding.
- •Allergy/Intolerance: Had Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Medication: a) Used an antimicrobial mouthwash within 48 hours of the test visit e.g. Listerine, Corsodyl etc. b) had taken, antibiotics within 2 weeks of the test visit.
- •Oral Surgery and Dental Conditions: a)Had an on-going dental treatment b) Had any oral surgery or extraction within 6 weeks of screening c) Symptoms of oral pain or any self-reported oral ulcers or herpetic lesions
- •Clinical Study Participation: a) Participation in a clinical study where they received an investigational drug within 2 weeks of the screening visit b) Previously participated in this study.
- •Substance Abstinence: Participant who were unwilling to abstain from smoking for at least 2 hours prior to treatment visits.
研究组 & 干预措施
Zinc-A toothpaste
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
干预措施: Zinc-A toothpaste (Drug)
Zinc-B toothpaste
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
干预措施: Zinc-B toothpaste (Drug)
Mineral Water
In this arm, participants received mineral water.
干预措施: Mineral water (Other)
结局指标
主要结局
Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique
时间窗: Change from baseline in log10-transformed AUC 0-2hr
Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr.
次要结局
- Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique(Baseline up to 2 hours)
- Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique(At Baseline, 30 minutes, 1 hour and 2 hours post-treatment)
- Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique(At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment)