drugset / Trial / NCT02617407

Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

NCT02617407 ↗

Phase 1 Completed 44 enrolled University of California, San Francisco
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2016-07-28
Primary completion
2020-01-27
Completion
2020-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Livionex Unknown — Oral
Comparator PreviDent 5000 plus Unknown — Oral
Comparator Tom's of Maine Children's toothpaste Unknown — Oral

Indications

No indication recorded.