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临床试验/NCT05601154
NCT05601154已完成早期 1 期

Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses

University of Michigan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Area under the curve of fluoride bioavailability in saliva

研究概览

简要总结

This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.

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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sign informed consent form
  • Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study
  • 18 years of age or older
  • Good general health
  • Good oral health, with no urgent treatment needs
  • Normal salivary flow rate

排除标准

  • Fail to understand or to agree to follow the study protocol
  • Reduced salivary flow rate
  • Poor general or oral health conditions

研究组 & 干预措施

Crest Cavity Protection

Active Comparator

Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

干预措施: Crest Cavity Protection toothpaste (Drug)

Crest Cavity Protection followed by Act Mint Fluoride Rinse

Active Comparator

Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm)

干预措施: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse (Drug)

Colgate PreviDent 5000+

Active Comparator

Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

干预措施: Colgate PreviDent 5000+ toothpaste (Drug)

Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse

Experimental

Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm)

干预措施: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse (Drug)

结局指标

主要结局

Area under the curve of fluoride bioavailability in saliva

时间窗: 0 to 60 minutes after the interventions

Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability

次要结局

  • Maximum fluoride concentration in saliva(0 to 60 minutes after the interventions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Livia Tenuta

Associate Professor

University of Michigan

研究点 (1)

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