Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Minimum pH
研究概览
简要总结
The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.
详细描述
Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to live in a non-fluoridated area
- •to have at least 20 natural teeth
- •signed a consent form agreeing to carefully follow the research instructions
排除标准
- •presence of active caries lesions
- •periodontal disease
- •use of antibiotics/medication.
研究组 & 干预措施
dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
干预措施: calcium glycerophosphate (Drug)
dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
干预措施: no active ingredient (Drug)
dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
干预措施: fluoride (Drug)
dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
干预措施: CAGP + fluoride (Drug)
结局指标
主要结局
Minimum pH
时间窗: at 1 minute (minimum fermenting pH) or at 7 minutes
The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.
Minimum pH After 14 Days of Use of Dentifrice
时间窗: 14 days
measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).
次要结局
未报告次要终点