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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05601154
• Other study ID #: HUM00212598
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: March 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	School of Dentistry, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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