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Livionex Toothpaste for Dental Plaque

Phase 4
Recruiting
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

Summary

This trial will test whether a new toothpaste can help reduce dental plaque in children undergoing chemotherapy, radiation treatment, or hematopoietic stem cell transplantation.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,557 Total Patients Enrolled
3 Trials studying Dental Plaque
358 Patients Enrolled for Dental Plaque
Pamela Den Besten, DDS, MSPrincipal InvestigatorSchool of Dentistry, UC San Francisco

Media Library

Livionex® Dental Gel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02617407 — Phase 4
Dental Plaque Research Study Groups: Livionex® Dental Gel, PreviDent 5000 plus/Tom's of Maine Children's toothpaste
Dental Plaque Clinical Trial 2023: Livionex® Dental Gel Highlights & Side Effects. Trial Name: NCT02617407 — Phase 4
Livionex® Dental Gel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02617407 — Phase 4
~4 spots leftby Jan 2025