What side effects are associated with this type of intervention?

Common treatments for dental plaque include mechanical methods like brushing and flossing, and chemical methods such as mouthwashes containing chlorhexidine or baking soda dentifrices. Chlorhexidine mouthwash is effective but can cause side effects like tooth staining, altered taste, and increased tartar formation. Baking soda dentifrices are generally safe but may cause mild irritation in some users. Livionex® toothpaste, which disrupts biofilm without causing gingival irritation, offers a promising alternative with fewer side effects compared to traditional chemical treatments.

What prior FDA approvals exist?

FDA-approved treatments for dental plaque typically include various types of toothpaste and mouth rinses that contain active ingredients like fluoride, triclosan, and essential oils. These products work by reducing plaque formation and disrupting biofilm. Livionex® toothpaste, which is being studied for its efficacy in reducing dental plaque without causing gingival irritation, represents a novel approach by targeting the biofilm directly. While specific FDA approvals for Livionex® are not mentioned, its mechanism of action aligns with the broader category of biofilm-disrupting dental care products.

What other types of research exist?

Promising novel alternatives to Livionex® toothpaste for dental plaque control in 2024 include: 1) Toothpastes containing enzymes like papain and bromelain, which break down biofilm. 2) Probiotic-based oral care products that promote beneficial bacteria to outcompete harmful plaque-forming bacteria. 3) Antimicrobial peptides incorporated in toothpaste formulations to target and disrupt biofilm. 4) Nanotechnology-based toothpastes that use nanoparticles to penetrate and break down biofilm. These alternatives aim to reduce dental plaque effectively while minimizing gingival irritation.

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Other

Livionex Toothpaste for Dental Plaque

Phase 1

Waitlist Available

Led By Pamela Den Besten, DDS, MS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 44 days - change from baseline to day 14 and 44 will be measured

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Livionex® toothpaste may have fewer side effects due to no additives that cause gum irritation; however, participants with specific allergies such as edathamil need caution as it could trigger allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 44 days - change from baseline to day 14 and 44 will be measured

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 44 days - change from baseline to day 14 and 44 will be measured

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 44 days - change from baseline to day 14 and 44 will be measured for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to oral hygiene

Gingival index score (Löe H, 1967)

Optical Coherence Tomography (OCT) score (Turesky modification of the Quigley-Hein Plaque Index, Ajaharain J, 2014)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Livionex® Dental Gel

2016

Completed Phase 1

~50

Kolibree Toothbrush

2016

Completed Phase 1

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dental plaque, such as Livionex® toothpaste, work by disrupting the biofilm that forms on teeth. Biofilm is a structured community of bacteria that adheres to the tooth surface, leading to plaque formation and potential dental issues like cavities and gum disease. Livionex® toothpaste is effective because it targets and breaks down this biofilm without causing gingival irritation, which is a common side effect of other toothpaste additives. This mechanism is crucial for dental plaque patients as it helps maintain oral hygiene, reduces the risk of oral infections, and promotes overall dental health without adverse effects.