Fluoride Toothpaste + Mouthrinse for Preventing Tooth Decay

Overseen By Livia M Tenuta, DDS, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Michigan

Disqualifiers: Reduced salivary flow, poor health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with good oral and general health, normal saliva flow, no urgent dental needs, living in Ann Arbor, MI. They must understand the study protocol and commit to its full duration. It's not for those with poor health or low saliva production.

Inclusion Criteria

My saliva flow is normal.

Sign informed consent form

I am in good overall health.

Exclusion Criteria

I understand and agree to follow the study's rules.

My overall or dental health is poor.

Reduced salivary flow rate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use different combinations of fluoride toothpaste and mouthrinse in a crossover design

4 weeks

Multiple visits for each treatment combination

Follow-up

Participants are monitored for fluoride bioavailability in saliva after treatment

1 week

1 visit (in-person) for final assessment

Treatment Details

Interventions

• Fluoride rinse
• Over-the-counter fluoride toothpaste
• Prescription fluoride toothpaste

Trial Overview The study tests fluoride availability in saliva after using two types of toothpaste (regular Crest Cavity Protection and prescription-strength Colgate PreviDent 5000+) alone or followed by Act Mint Fluoride Rinse. Participants will try all four combinations in a crossover design.

Participant Groups

Group I: Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse Experimental Treatment 1 Intervention

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 II: Colgate PreviDent 5000+ Active Control 1 Intervention

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

Group III: Crest Cavity Protection Active Control 1 Intervention

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

Group IV: Crest Cavity Protection followed by Act Mint Fluoride Rinse Active Control 1 Intervention

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)

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+