Toothpaste Tablets for Dental Health

Not yet recruiting at 1 trial location

Overseen By So Ran Kwon, DDS, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Loma Linda University

Disqualifiers: Under 18

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of toothpaste tablets and regular toothpaste in cleaning teeth. Participants are divided into two groups: one uses toothpaste tablets, and the other uses conventional toothpaste, both for six weeks. The study measures changes in plaque and gum health before and after using the products. Individuals with more than 20 teeth who are willing to follow the study's guidelines may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new dental care option.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

A previous study on similar toothpaste products reported no significant mouth irritation, suggesting that toothpaste tablets are generally gentle on the mouth. Designed for daily use, the tablets contain fewer ingredients than regular toothpaste, potentially reducing the chance of side effects. Overall, research indicates that toothpaste tablets are safe for use. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Toothpaste tablets are unique because they offer a new delivery method for maintaining dental health. Unlike traditional toothpaste, which comes in a tube, these tablets are compact and mess-free, making them perfect for travel or quick brushing on the go. Researchers are excited about toothpaste tablets because they simplify the brushing process without compromising effectiveness, ensuring consistent use and optimal dental hygiene. Additionally, the tablets may offer more precise dosing, potentially reducing waste and improving oral health outcomes.

What evidence suggests that this trial's treatments could be effective for dental health?

This trial will compare the effectiveness of toothpaste tablets with conventional toothpaste. Studies have shown that toothpaste tablets containing 5% nanohydroxyapatite perform as well as regular fluoride toothpastes in maintaining oral health. Research indicates that these tablets can remove plaque effectively, similar to traditional toothpastes. Tests measuring gum health and plaque levels have shown that toothpaste tablets yield results comparable to regular toothpaste. Additionally, a study comparing these tablets with fluoride toothpaste found they were equally effective at removing plaque in children. These findings suggest that toothpaste tablets could serve as a good alternative for maintaining healthy teeth and gums. ^{4 6 7 8 9}

Who Is on the Research Team?

So Ran Kwon, DDS, MS, PhD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for individuals interested in oral health, specifically those who want to test the effectiveness of toothpaste tablets compared to conventional toothpaste. Participants should be willing to use their assigned product for 6 weeks and complete a questionnaire.

Inclusion Criteria

Subjects who will comply with study protocol

I am 18 years old or older.

Subjects who can read and understand the consent form

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use assigned dentifrice for 6 weeks with pre and post-assessment of Gingival Index, Plaque Index, and DMFT

6 weeks

2 visits (in-person)

Follow-up

Participants complete a questionnaire on product use and are monitored for any delayed effects

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Toothpaste
• Toothpaste Tablets

Trial Overview The study tests if Denttabs toothpaste tablets are as effective as Colgate's Cavity Protection toothpaste in removing plaque and improving gum health. It involves pre and post assessments of dental health over a period of 6 weeks with 50 participants split into two groups.

How Is the Trial Designed?

Group I: Toothpaste Tablet Experimental Treatment 1 Intervention

Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.

Group II: Conventional Toothpaste Active Control 1 Intervention

Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110711/

Evaluation of the Efficacy of a Dentifrice Tablet to Prevent ... The present study demonstrated that dentifrice tablets containing 5% nanohydroxyapatite are as effective as NaF toothpastes containing 1100 ppm fluoride in ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT05805865/Prot_SAP_000.pdf

Study Title: Efficacy of Eco-Friendly Toothpaste Tablets ... We aim to evaluate this by, measuring gingival index (GI) and the plaque index (PI) on subjects that have been either using the tabs or toothpaste. We ...

3. dentistry.llu.edu dentistry.llu.edu/sites/dentistry.llu.edu/files/2023-08/research-aug-2023.pdf

A comparison of toothpaste tablets and a sodium fluoride ... ABSTRACT: Purpose: To compare toothpaste tablets containing 0.243% sodium fluoride and a conventional sodium.

4. journals.lww.com journals.lww.com/sjed/fulltext/2022/09030/a_comparative_clinical_evaluation_of_plaque.9.aspx

A comparative clinical evaluation of plaque removal efficacy This study aimed to compare the plaque removal efficacy of a novel chewable toothpaste tablet and a traditional toothpaste in children aged 6–12 years old.

5. mdpi.com mdpi.com/1996-1944/18/20/4804

Physical and Functional Properties of Toothpaste Tablets Toothpaste pH plays a key role not only in its effectiveness but also in maintaining oral health. Fernandez et al. [48] demonstrated that appropriately ...

6. premierdentalco.com premierdentalco.com/wp-content/uploads/2015/07/SDS_Enamelon_Toothpaste_R3.pdf

Safety Data Sheet Human long-term safety-in-use studies on similar toothpaste products resulted in no significant product-related oral irritation effects.

7. ada.org ada.org/resources/ada-library/oral-health-topics/toothpastes

Toothpastes All dentifrices at or below 2.5 times the reference value, or 250 RDA, are considered safe and effective.24 Clinical evidence suggests lifelong ...

8. fda.gov fda.gov/media/189421/download

Fluoride Ingestible Drug Products | FDA Scientific Evaluation To better understand the possible health risks of ingestible fluoride drug products in children,33. FDA reviewers evaluated data from a variety ...

9. patents.google.com patents.google.com/patent/WO2024041876A1/en

WO2024041876A1 - Toothpaste tablet composition The application discloses the composition of a superior toothpaste tablet with excellent organoleptic properties and suitable long-term stability.