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

Early Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Drug: Crest Cavity Protection toothpaste; Drug: Colgate PreviDent 5000+ toothpaste; Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse; Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse

• Registration Number: NCT05601154
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-11-01
• Study Start: 2023-03-23
• Primary Completion: 2024-11-04
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crest Cavity Protection	Crest Cavity Protection toothpaste	Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water
Colgate PreviDent 5000+	Colgate PreviDent 5000+ toothpaste	Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water
Crest Cavity Protection followed by Act Mint Fluoride Rinse	Crest Cavity Protection toothpaste 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)
Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse	Colgate PreviDent 5000+ toothpaste 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)

Primary Outcome Measures

Name	Time	Method
Area under the curve of fluoride bioavailability in saliva	0 to 60 minutes after the interventions	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Dentistry, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States