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

44 Participants Needed

Trial Summary

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.

How does Livionex® Dental Gel differ from other treatments for dental plaque?

Livionex® Dental Gel is unique because it contains 2.6% edathamil, which is designed to improve the surface microhardness and microstructure of enamel, potentially offering a novel approach to dental plaque management compared to traditional toothpastes that primarily focus on cleaning and polishing teeth. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial uses Livionex® toothpaste to help children undergoing cancer treatments maintain better oral hygiene. These children are targeted because their treatments make it difficult for them to keep their mouths clean, increasing their risk of infections. The toothpaste works by reducing plaque and inflammation, which may help prevent serious infections.

Research Team

Pamela Den Besten, DDS, MS

Principal Investigator

School of Dentistry, UC San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a Novel Dental Gel on Enamel Surface Recovery from Acid Challenge. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Double-Blinded, Randomized Study Evaluating the In Vivo Effects of a Novel Dental Gel on Enamel Surface Microstructure and Microhardness. [2019]

3. Israel pubmed.ncbi.nlm.nih.gov

[Toothpastes: ingredients, brands, categories and their utilization]. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Antiplaque and antigingivitis toothpastes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

In situ effect of fluoride toothpaste supplemented with nano-sized sodium trimetaphosphate on enamel demineralization prevention and biofilm composition. [2019]