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Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

NCT02617407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-09-23

No results posted yet for this study

Summary

Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in reducing dental plaques while containing no additives found in other toothpastes that can cause increased gingival irritation. The investigators hypothesize that improved oral hygiene and better plaque control in pediatric patients receiving chemo/radiation treatment or HSCT may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot study is to determine whether incorporation of the Livionex® toothpaste in the research regimen could reduce dental plaque.

Conditions

  • Dental Plaque

Interventions

DRUG

Livionex® Dental Gel

Oral application Dental Plaque, Gingivitis and Oral Microbiome Control.

DRUG

PreviDent 5000 plus/Tom's of Maine Children's toothpaste

Oral application for Dental Plaque, Gingivitis and Oral Microbiome Control.

DEVICE

Kolibree Toothbrush

Electric Toothbrush

Sponsors & Collaborators

Principal Investigators

  • Pamela Den Besten, DDS, MS · School of Dentistry, UC San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-28
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617407 on ClinicalTrials.gov