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Summary

at San Francisco, California
study started
estimated completion:

Description

Summary

Children undergoing 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 in HSCT recipients and better plaque control 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.

Official Title

Pilot Study -- Oral Microbiome and Dental Plaque Control With Livionex(R) in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Details

This is a prospective randomized (2:1) pilot study. A total of 30 children undergoing HSCT who are able to cooperate with saliva collection and dental exams will be enrolled into this study.

Rational:

As chemotherapy and radiation therapy result in a break-down of the mucosal barrier, HSCT recipients are at a significant risk for bacteremia and sepsis from oral pathogens. Children undergoing HSCT have significant difficulties achieving good oral hygiene and dental plaque control because of sensitivity of oral tissues leading to intolerance of teeth brushing and standard dentifrice. This usually results in plaque buildup and moderate to severe gingival inflammation, which persists during and after transplantation. The investigators hypothesize that improved oral hygiene and better plaque control in HSCT recipients may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related bacterial infections.

Primary Objectives:

To evaluate adherence to oral hygiene by using daily compliance logs and to evaluate the efficacy of Livionex® as compared to standard toothpaste PreviDent® 5000 plus in plaque and gingivitis reduction in HSCT recipients.

Study duration:

Therapy 7 days and follow-ups is up to 44 days. It will take 25 months to enroll patients and complete follow-up.

Safety Assessments:

The incidence of bacteremia with oral pathogens will be followed up to 44 days after first day of intervention. The investigators anticipate that the risk of bacteremia caused by oral pathogens will decrease with study procedures; however, if significantly increased incidence of bacteremia with oral pathogens is documented in either cases or controls, the study will be stopped.

Efficacy:

The investigators will measure adherence to the protocol of teeth brushing twice per day using test and control dentifrice. The investigators will evaluate the change in dental plaque scores and gingival inflammation from day 0 to 7, and 44 for each patient, as well as compare plaque scores and gingival inflammation between the test and control groups.

At baseline, day 7, and day 44, optical coherence tomography will be used to image and thereby quantify plaque presence. Also, plaque staining will be performed and standardized photographs taken to allow for plaque distribution mapping. On these same days, saliva samples will be collected and 1.0 mL of blood will be taken during the daily morning blood draw. Saliva (2.0 mL) will be cultured for total viable bacteria and oral streptococci. Saliva and blood will be assessed for full bacterial profile using shotgun sequencing (microbiome).

Unique Aspects of This Study:

This study uses a new dentifrice that has been shown to improve plaque control in pediatric HSCT recipients with the goal of improving plaque control during HSCT. This is the first study exploring the composition of plaque and oral microbiome in pediatric HSCT recipients. This study will gather data on the possible link between the oral microbiome and systemic bacteremia during HSCT, the effect of plaque reduction on oral microbiome, and the effect of systemic antibiotic use on oral microbiome.

Keywords

Dental Plaque Gingivitis Bacterial Infection Oral Hygiene HSCT Oral Microbiome Sodium Fluoride Listerine

Eligibility

You can join if…

  • HSCT recipient who can cooperate with study procedures.
  • Parents and patient willing to participate and sign informed consent and assent forms.

You CAN'T join if...

  • Unable to understand or participate in study procedures.
  • Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02617407
Lead Scientist
Pamela Den Besten
Study Type
Interventional
Last Updated
November 1, 2016
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