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

NCT05601154 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HUM00212598
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Area under the curve of fluoride bioavailability in saliva

  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

  0 to 60 minutes after the interventions

Secondary Outcomes (1)

• Maximum fluoride concentration in saliva

  0 to 60 minutes after the interventions

Study Arms (4)

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

Drug: Crest Cavity Protection toothpaste

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)

Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse

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

Drug: Colgate PreviDent 5000+ toothpaste

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)

Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse

Interventions

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

Also known as: Over-the-counter fluoride toothpaste followed by water rinse

Crest Cavity Protection

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

Also known as: Over-the-counter fluoride toothpaste followed by fluoride rinse

Crest Cavity Protection followed by Act Mint 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

Also known as: Prescription fluoride toothpaste followed by water rinse

Colgate PreviDent 5000+

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

Also known as: Prescription fluoride toothpaste followed by fluoride rinse

Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: March 23, 2023
• Primary Completion: November 4, 2024
• Study Completion: February 28, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-03

Locations

US (1)