The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery (% SMHR)
研究概览
简要总结
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
- •Participants with maxillary dental arch suitable for the retention of the palatal appliance
排除标准
- •Participants taking fluoride supplement
- •Pregnant or breast-feeding women
研究组 & 干预措施
Sodium fluoride (1426 ppm)
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
干预措施: Sodium fluoride (1426 ppm) (Drug)
Sodium fluoride (1150 ppm)
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
干预措施: Sodium fluoride (1150 ppm) (Drug)
Sodium fluoride (250 ppm)
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
干预措施: Sodium fluoride (250 ppm) (Drug)
Sodium fluoride (1426 ppm) + zinc base A
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
干预措施: Sodium fluoride (1426 ppm) + zinc base A (Drug)
Sodium fluoride (1426 ppm) + zinc base B
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
干预措施: Sodium fluoride (1426 ppm) + zinc base B (Drug)
Fluoride (0 ppm)
Non-zinc, 0ppm fluoride in a silica gel base
干预措施: Fluoride (0 ppm) (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery (% SMHR)
时间窗: Baseline to 4 hours
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= \[(D1-R)/(D1-B)\]\*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
次要结局
- Percentage Comparative Acid Resistance (% CAR)(Baseline to 4 hours)
- Enamel Fluoride Uptake(Baseline to 4 hours)
- Percentage Net Acid Resistance (% NAR)(Baseline to 4 hours)