44 Participants Needed

Livionex Toothpaste for Dental Plaque

YL
Overseen ByYing Lu, PhD
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

Who Is on the Research Team?

PD

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Livionex® Dental GelExperimental Treatment2 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 toothpasteActive Control2 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Effects of a Novel Dental Gel on Enamel Surface Recovery from Acid Challenge. [2020]
A Double-Blinded, Randomized Study Evaluating the In Vivo Effects of a Novel Dental Gel on Enamel Surface Microstructure and Microhardness. [2019]
[Toothpastes: ingredients, brands, categories and their utilization]. [2015]
Antiplaque and antigingivitis toothpastes. [2022]
In situ effect of fluoride toothpaste supplemented with nano-sized sodium trimetaphosphate on enamel demineralization prevention and biofilm composition. [2019]
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