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

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Dental Caries

Treatments: Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse; Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse; Drug: Colgate PreviDent 5000+ toothpaste; Drug: Crest Cavity Protection toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT05601154

HUM00212598

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Crest Cavity Protection

Active Comparator group

Description:

Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

Treatment:

Drug: Crest Cavity Protection toothpaste

Crest Cavity Protection followed by Act Mint Fluoride Rinse

Active Comparator group

Description:

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)

Treatment:

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

Colgate PreviDent 5000+

Active Comparator group

Description:

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

Treatment:

Drug: Colgate PreviDent 5000+ toothpaste

Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse

Experimental group

Description:

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)

Treatment:

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