Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Calcium concentration in saliva at 45 seconds
研究概览
简要总结
The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Reported good general health
- •Reported good oral health
- •Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
- •Having normal salivary flow rate according to direct flow rate determination methods
- •Agreement to adhere to the study protocol
排除标准
- •Unable to understand and/or follow study instructions
- •Hyposalivation
- •Active periodontitis, identified by frequent bleeding of the gums
- •Oral pain
- •In need of urgent dental care
研究组 & 干预措施
Chewing calcium supplements
Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions.
Participants were randomized to determine the sequence of exposure to the different treatments.
干预措施: Inactive supplement (Drug)
Chewing calcium supplements
Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions.
Participants were randomized to determine the sequence of exposure to the different treatments.
干预措施: Tricalcium phosphate supplement (Drug)
Chewing calcium supplements
Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions.
Participants were randomized to determine the sequence of exposure to the different treatments.
干预措施: Calcium carbonate supplement (Drug)
Chewing calcium supplements
Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions.
Participants were randomized to determine the sequence of exposure to the different treatments.
干预措施: Calcium citrate supplement (Drug)
Fluoride rinse
Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement.
干预措施: Inactive supplement and fluoride mouthwash (Drug)
Fluoride rinse
Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement.
干预措施: Calcium carbonate supplement and fluoride mouthwash (Drug)
Fluoride rinse
Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement.
干预措施: Calcium citrate supplement and fluoride mouthwash (Drug)
结局指标
主要结局
Calcium concentration in saliva at 45 seconds
时间窗: 45 seconds after chewing calcium supplement
Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at baseline
时间窗: Baseline
Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in the mixture of saliva and chewed calcium supplement
时间窗: Immediately after the 30-second chewing of calcium supplement
Saliva and remnants of the chewed calcium supplement collected at the end of the chewing period (30 seconds) in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 15 seconds
时间窗: 15 seconds after chewing calcium supplement
Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 30 seconds
时间窗: 30 seconds after chewing calcium supplement
Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Fluoride concentration in saliva at time 0
时间窗: 0 minutes after chewing supplement/mouthwashing
Saliva and remnants of the fluoride mouth rinse collected at the end of the rinsing period (1 minute) in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Calcium concentration in saliva at 60 seconds
时间窗: 60 seconds after chewing calcium supplement
Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 120 seconds
时间窗: 120 seconds after chewing calcium supplement
Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 180 seconds
时间窗: 180 seconds after chewing calcium supplement
Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 240 seconds
时间窗: 240 seconds after chewing calcium supplement
Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 300 seconds
时间窗: 300 seconds after chewing calcium supplement
Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Area under the curve of calcium concentration in saliva
时间窗: Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
Calcium concentration in saliva collected at baseline (before chewing the supplements), and 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing the supplements in Arm 1 expressed as the area under the curve of calcium concentration in saliva as a function of time (milimolar x min).
Fluoride concentration in saliva at baseline
时间窗: Baseline
Saliva will be collected for 2 min, immediately before chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Fluoride concentration in saliva at 5 min
时间窗: 5 minutes after chewing supplement/mouthwashing
Saliva will be collected for 2 min, 5 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Fluoride concentration in saliva at 30 min
时间窗: 30 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 30 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 15 min
时间窗: 15 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 15 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 60 min
时间窗: 60 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 60 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 120 min
时间窗: 120 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 120 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Area under the curve of fluoride concentration in saliva
时间窗: Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva collected at baseline (before treatments), and 0, 5, 15, 30, 60 and 120 minutes after chewing the supplements and/or rinsing the fluoride mouthrinse in Arm 2 expressed as the area under the curve of fluoride concentration in saliva as a function of time (micromolar x min).
次要结局
未报告次要终点
研究者
Livia Tenuta
DDS, MS, PhD, Associate Professor
University of Michigan