Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

This is a prospective randomized (2:1) pilot study. A total of 75 children undergoing HSCT or
chemo/radiation therapy for cancer treatment 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 and cancer patients 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 and cancer patients 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 and children receiving chemo/radiation therapy for
cancer treatment.

Study duration:

Therapy 7 days and follow-ups is up to 44 days. It will take 36 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 14, and 44 for each patient, as well as
compare plaque scores and gingival inflammation between the test and control groups.

At baseline, day 14, 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/dental
plaque, stool and blood specimens will be collected to assess for full bacterial profile
(microbiome).

Unique Aspects of This Study:

This study uses a new dentifrice that has been shown to improve plaque control in pediatric
cancer patients and 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 and gut
microbiome with systemic bacteremia during HSCT, the effect of plaque reduction on oral
microbiome, and the effect of systemic antibiotic use on oral microbiome.

Inclusion Criteria:

- HSCT recipient or chemo/radiation therapy patients who can cooperate with study
procedures.

- Parents and patient willing to participate and sign informed consent and assent forms.

Exclusion Criteria:

- Unable to understand or participate in study procedures.

- Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.