Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses

Completed · Early Phase 1

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT05601154

Run by

University of Michigan

People needed

20

Starts

2023-03-23

Expected to finish

2025-02-28

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• School of Dentistry, University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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