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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of fluoride from toothpaste and mouthrinse in preventing tooth decay. Researchers aim to measure how much fluoride remains in saliva after using various toothpaste and mouthrinse combinations. The trial includes four groups, each testing a different mix of over-the-counter or prescription fluoride toothpaste and fluoride rinse. Ideal participants have healthy teeth and gums, no urgent dental needs, and normal saliva levels, and reside in Ann Arbor, MI. As an Early Phase 1 trial, this research seeks to understand how fluoride treatments function in people, providing participants an opportunity to contribute to foundational dental health research.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on oral health and fluoride use, so it's best to ask the study team for clarification.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fluoride toothpaste and mouthrinse are generally safe for most people. For instance, Colgate PreviDent 5000+ is a prescription toothpaste with a high fluoride level, often recommended for those at high risk of cavities. Adults usually tolerate it well, but it is not suitable for young children or those who have trouble swallowing.

Similarly, Act Mint Fluoride Rinse, available without a prescription, contains a lower fluoride level and is used by many without major issues. It helps protect teeth just like fluoride toothpaste.

Studies have demonstrated that these products are safe for everyday use in healthy adults. However, some individuals might experience minor side effects, such as mouth irritation. If there is uncertainty about which products are suitable, consulting a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine high-concentration fluoride toothpaste with a fluoride mouth rinse, potentially offering enhanced protection against tooth decay. Unlike standard over-the-counter toothpastes that usually contain around 1,100 ppm of fluoride, the prescription toothpaste used here contains 5,000 ppm, which could provide stronger enamel protection. Additionally, the use of Act Mint Fluoride Rinse after brushing introduces an extra layer of fluoride, which might help in further reducing the risk of cavities. This combination approach is what sets these treatments apart, aiming to maximize fluoride exposure and improve oral health outcomes.

What evidence suggests that this trial's treatments could be effective for preventing tooth decay?

Research has shown that high-fluoride toothpaste, such as Colgate PreviDent 5000+, can significantly reduce cavities. It repairs tooth decay on roots by 38% in three months and 57% in six months. This trial will test Colgate PreviDent 5000+ both alone and with Act Mint Fluoride Rinse. Studies also find that toothpaste with 5,000 ppm fluoride hardens teeth more than those with less fluoride. Using this toothpaste with a fluoride mouthrinse may increase fluoride levels in saliva, helping to prevent tooth decay. Overall, strong evidence supports the effectiveness of these high-fluoride products in reducing cavities and strengthening teeth. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4282025/

High-fluoride toothpaste: a multicenter randomized ... It has been suggested that an increase of 500 ppm F within the range of 1100–2500 ppm F, results in an additional 6% caries reduction,. Fluoride toothpastes ...

2. colgateprofessional.com colgateprofessional.com/products/prescription-only-products/colgate-prevident-5000-plus-prescription-strength

Colgate® PreviDent® 5000 Plus (1.1% Sodium Fluoride) ... PreviDent 5000 Plus is clinically proven to significantly remineralize root caries by 38% in less than 3 months, and by 57% in 6 months.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05601154?term=Fluoride%20Ion&rank=9

Study Details | NCT05601154 | Fluoride in Saliva After Use ... Drug : Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse. Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) ...

4. colgateprofessional.com colgateprofessional.com/products/prescription-only-products/colgate-prevident-5000-dry-mouth-prescription-strength

Colgate® PreviDent® 5000 ppm Dry Mouth (1.1% Sodium ... It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6784461/

Remineralization of Demineralized Enamel and Dentine ... The efficacy of fluoride dentifrices in the prevention and repair of enamel caries cannot be directly extrapolated to dentine. Remineralization ...

6. colgateprofessional.com colgateprofessional.com/products/prescription-only-products/colgate-prevident-dental-rinse-prescription-strength

Colgate® PreviDent® Rinse (0.2% Neutral Sodium ... IMPORTANT SAFETY INFORMATION: PreviDent Dental Rinse is contraindicated in patients with dysphagia, and for pediatric patients under age 6 unless recommended by ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05601154?term=Fluoride%20Ion&viewType=Table&rank=9

Study Details | Fluoride in Saliva After Use of ... 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- ...

8. colgate.com colgate.com/en-us/products/prescription-only-products/colgate-prevident-dental-rinse-prescription-strength

Colgate® PreviDent® Rinse (0.2% Neutral Sodium ... Containing the highest fluoride concentration for home use, this rinse provides full mouth coverage that's safe for restorations. The convenient dose cap makes ...

9. webmd.com webmd.com/drugs/2/drug-177382/sodium-fluoride-5000-plus-dental/details

Fluoride Dental (Clinpro 5000, PreviDent, and Others) Note: The FDA has not reviewed some forms of this medicine for safety and effectiveness, and some labels are not approved by the FDA. Learn more ...

10. henryschein.com henryschein.com/prevident-5000-sensitive.aspx

Colgate PreviDent 5000: Sensitive Toothpaste Colgate PreviDent 5000 products are the ideal therapy for patients with high risk for caries, dry mouth and hypersensitivity, as well as patients with ...