Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

NCT ID: NCT02617407

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-28
• Study Completion Date: 2020-01-27

Brief 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.

Detailed Description

This is a prospective randomized (2:1) pilot study of children undergoing HSCT or chemo/radiation therapy for cancer treatment who are able to cooperate with saliva collection and dental exams.

RATIONALE:

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:

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.

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Livionex® Dental Gel

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 Type: EXPERIMENTAL

Livionex® Dental Gel

Intervention Type: DRUG

Oral application Dental Plaque, Gingivitis and Oral Microbiome Control.

Kolibree Toothbrush

Intervention Type: DEVICE

Electric Toothbrush

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Kolibree Toothbrush

Intervention Type: DEVICE

Electric Toothbrush

Interventions

Livionex® Dental Gel

Oral application Dental Plaque, Gingivitis and Oral Microbiome Control.

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Kolibree Toothbrush

Electric Toothbrush

Intervention Type: DEVICE

Other Intervention Names

Edathamil; Over the counter toothpaste

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Den Besten, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry, UC San Francisco

Locations

University of California

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2019-00244

Identifier Type: REGISTRY

Identifier Source: secondary_id

160814

Identifier Type: OTHER

Identifier Source: secondary_id

15-18297

Identifier Type: -

Identifier Source: org_study_id