Livionex Toothpaste for Dental Plaque

Overseen By Ying Lu, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Francisco

Disqualifiers: Allergy to edathamil, others

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

Compensation: Varies

Number of Visits: 14

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Livionex® Dental Gel can help children undergoing chemotherapy, radiation, or stem cell transplants maintain cleaner and healthier mouths. These children often struggle with dental plaque, which can lead to serious infections. Participants will use either Livionex® or another toothpaste for two weeks, and researchers will assess whether Livionex® is more effective at reducing plaque and inflammation. The trial seeks children undergoing these treatments who can adhere to the study procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially beneficial treatment.

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

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

Is there any evidence suggesting that Livionex® Dental Gel is likely to be safe for humans?

Research shows that Livionex Dental Gel is safe for use. Designed to reduce dental plaque, this gel has been proven to remove plaque 250% better than some leading brands. All ingredients in Livionex are safe to ingest and contain no harsh substances, making them gentle on the mouth.

Earlier studies demonstrated that Livionex significantly reduced plaque compared to other dental gels. One study found an 86% reduction in plaque and noted improved gum health. This indicates that Livionex is not only effective but also well-tolerated, with no known harmful side effects.

As this is a Phase 1 trial, the main goal is to ensure safety. Based on past data and the ingredients used, Livionex appears safe for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Livionex® Dental Gel is unique because it targets dental plaque at its core by disrupting the biofilm that plaque bacteria use to stick to teeth. Traditional toothpastes often rely on abrasives or antimicrobials, which can take longer to have an effect. In contrast, Livionex uses a new mechanism involving activated edathamil, which helps remove plaque more effectively and quickly. Researchers are excited about this treatment because it promises faster and potentially more efficient plaque removal, potentially leading to healthier teeth and gums in a shorter time frame.

What evidence suggests that Livionex® Dental Gel could be effective for reducing dental plaque in children undergoing chemotherapy, radiation treatment, or HSCT?

Research has shown that Livionex® Dental Gel, which participants in this trial may use, effectively reduces dental plaque. One study found that people using Livionex experienced an 86% reduction in plaque, compared to a 33% reduction with a regular dental gel like Colgate Total. This indicates that Livionex is significantly better at controlling plaque. The gel also lacks additives that can irritate gums, commonly found in other toothpastes, making it a promising choice for improving oral health, especially for children undergoing treatments like chemotherapy or stem cell transplants. Participants in another arm of this trial will use PreviDent 5000 Plus or Tom's of Maine Children's toothpaste as a comparator. ^{2 4 6 7 8}

Who Is on the Research Team?

Pamela Den Besten, DDS, MS

Principal Investigator

School of Dentistry, UC San Francisco

Are You a Good Fit for This Trial?

This trial is for children receiving chemotherapy, radiation, or Hematopoietic Stem Cell Transplantation (HSCT) who can follow the study's procedures. They and their parents must be willing to participate and sign consent forms. It's not for those with an allergy to edathamil or multiple hygiene/cosmetic products.

Inclusion Criteria

HSCT recipient or chemo/radiation therapy patients who can cooperate with study procedures

Parents and patient willing to participate and sign informed consent and assent forms

Exclusion Criteria

Unable to understand or participate in study procedures

Known allergy to edathamil

Known allergy to multiple hygiene and cosmetic products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use Livionex or PreviDent 5000 plus/Tom's of Maine toothpaste for daily teeth brushing

7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including plaque and gingival index assessments

44 days

Assessments at day 14 and day 44

What Are the Treatments Tested in This Trial?

Interventions

• Livionex® Dental Gel

Trial Overview The trial tests if Livionex® toothpaste can better control dental plaque compared to standard toothpastes like PreviDent 5000 plus/Tom's of Maine Children's, using a Kolibree Toothbrush. The goal is to see if it reduces oral inflammation and the risk of infections in these vulnerable patients.

How Is the Trial Designed?

Group I: Livionex® Dental Gel Experimental Treatment 2 Interventions

Study patients assigned to this arm will use Livionex toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment.

Group II: PreviDent 5000 plus/Tom's of Maine Children's toothpaste Active Control 2 Interventions

Study patients assigned to this arm will use PreviDent 5000 plus or Tom's of Maine Children's (age 6 years and younger) toothpaste for daily teeth brushing from day 1 to day 14. Study participants will be encouraged to continue use study toothpaste and monitored up to 44 days after study enrollment.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04368533

Livionex on Reducing Plaque Accumulation and Improving ... Changes of dental plaque, To compare plaque reduction between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454341/

Effects of a Novel Dental Gel on Plaque and Gingivitis showed an 86% reduction in plaque in the test dental gel (Livionex) compared to a 33% reduction for the control dental gel (Colgate TotalR). The mSBI showed ...

3. escholarship.org escholarship.org/content/qt04p7d8wz/qt04p7d8wz_noSplash_c7c1b3adc27749aa36bf3b6644f4da92.pdf?t=qm1p6b

A Pilot Study to Evaluate the Effect of Livionex on Reducing ... The study hypothesis was that brushing with Livionex dental gel would result in greater plaque reduction, and caries inhibition equal to that of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02617407

Livionex Oral Microbiome and Dental Plaque Control in ... Livionex® toothpaste was shown to be effective in reducing dental plaques while containing no additives found in other toothpastes that can cause increased ...

5. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/cgi/viewcontent.cgi?article=1396&context=etd-collection

Randomized Control Trial of a Novel Dental Gel as an Adjunct ... The study found that there was an 86% reduction in plaque in the LivFresh dental gel compared to a 33% reduction for the Colgate Total (triclosan co-polymer) ...

6. getlivfresh.com getlivfresh.com/pages/sales-letter-style-advertorial-dangers-of-plaque?srsltid=AfmBOooHvFpzAeQFL3FZxeJ0k5gVOFOwm0dlyvgiPRxHenhTiIs6JXZw

Sales Letter Style Advertorial - Dangers of Plaque Now I use LIVFRESH Dental Gel, which is a form of toothpaste, but it chemically attacks the plaque that's built up on the teeth.” Founder of Dyson Vacuums Sir ...

7. livionex.com livionex.com/oral-care/

Oral Care LIVFRESH Dental Gel toothpaste is clinically proven to remove plaque 250% BETTER than a market leader. All ingredients are edible and contain ZERO abrasives.

8. amazon.com amazon.com/LIVFRESH-Dental-Gel-Livionex-Wintergreen/dp/B07PQYJBM3

LIVFRESH Toothpaste Gel, Clinically Proven to Remove ... Clinically proven to remove plaque 250% better, improves gum health 190% better, prevents & reduces tartar, freshens breath, SLS free dental gel.