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

NCT ID: NCT05601154

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Crest Cavity Protection toothpaste

Intervention Type: 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

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)

Group Type: ACTIVE_COMPARATOR

Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse

Intervention Type: 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

Colgate PreviDent 5000+

Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

Group Type: ACTIVE_COMPARATOR

Colgate PreviDent 5000+ toothpaste

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Over-the-counter fluoride toothpaste followed by water rinse; Over-the-counter fluoride toothpaste followed by fluoride rinse; Prescription fluoride toothpaste followed by water rinse; Prescription fluoride toothpaste followed by fluoride rinse

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Livia Tenuta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry, University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00212598

Identifier Type: -

Identifier Source: org_study_id