drugset / Trial / NCT05601154

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

NCT05601154

Phase 0 Completed 20 enrolled University of Michigan
RandomizedCrossoverSingle-blindPrevention

Summary

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.

Timeline

Start
2023-03-23
Primary completion
2024-11-04
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Act Mint Fluoride Rinse Unknown 226 ppm Oral
Comparator Colgate PreviDent 5000+ toothpaste Unknown 5000 ppm Oral
Comparator Fluoride Other / unclassified 1100 ppm Oral

Indications