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Completed

NCT Number: NCT05601154

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Crest cavity protection toothpaste

Drug

Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds

Other names: Over-the-counter fluoride toothpaste followed by water rinse

Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse

Drug

Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute

Other names: Over-the-counter fluoride toothpaste followed by fluoride rinse

Colgate PreviDent 5000+ toothpaste

Drug

Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds

Other names: Prescription fluoride toothpaste followed by water rinse

Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse

Drug

Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute

Other names: Prescription fluoride toothpaste followed by fluoride rinse

Primary outcomes

  1. Area under the curve of fluoride bioavailability in saliva

    Time frame: 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

Secondary outcomes

  1. Maximum fluoride concentration in saliva

    Time frame: 0 to 60 minutes after the interventions

    From the area under the curve, the time at which the concentration in saliva is highest will be determined

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 1, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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