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

Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Crest Cavity Protection toothpaste; Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse; Drug: Colgate PreviDent 5000+ toothpaste; Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • School of Dentistry, University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Crest Cavity Protection; 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; 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
Active Comparator: Crest Cavity Protection followed by Act Mint Fluoride Rinse; 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; 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
Active Comparator: Colgate PreviDent 5000+; 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; 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
Experimental: Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum fluoride concentration in saliva	From the area under the curve, the time at which the concentration in saliva is highest will be determined	0 to 60 minutes after the interventions

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: HUM00212598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No