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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

Study 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 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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,480 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the cohort for this research trial?

"Affirmative. The clinicaltrials.gov website clarifies that this medical trial, which was initially posted on August 2nd 2016, is presently seeking participants. Specifically, 75 patients must be enrolled at a single location in order to move forward with the study."

Answered by AI

Is the application of Livionex® Dental Gel safe for patients?

"The safety of Livionex® Dental Gel is given a rating of 3 because it's already been through Phase 4 trials, signifying that the product has obtained regulatory approval."

Answered by AI

What prior experiments have employed Livionex® Dental Gel to evaluate its efficacy?

"Currently, there are 8 active clinical studies for the Livionex® Dental Gel with two of these trials being conducted in Phase 3. The majority of research is taking place in Santiago, Región Metropolitana while 15 other sites across the globe are also running tests."

Answered by AI

What maladies is Livionex® Dental Gel traditionally administered to address?

"Livionex® Dental Gel is an effective means of managing dentures, administering parenteral nutrition and combatting dental decay."

Answered by AI

Is this trial currently enrolling participants?

"According to clinicaltrials.gov, this medical investigation is currently in the process of enrolling suitable participants. It was initially announced on August 2nd 2016 and has been amended for the last time on February 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

2016. "Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02617407.

All > Microbiome