Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

NCT02617407 | Completed Phase 1 FDA Drug

• 3 other identifiers: 15-18297NCI-2019-00244160814
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque

Keywords

Dental Plaque; Gingivitis; Bacterial Infection; Oral Hygiene; HSCT; Oral Microbiome; Gut Microbiome; Blood Microbiome

Outcome Measures

Primary Outcomes (4)

• Adherence to oral hygiene

  Compliance will be recorded two times daily, units on a scale 0 - 2 (2 = excellent compliance, 0 = no compliance). A mean score from day 1 to 7 will be compared (t-test) for each patient and between the treatment and the control group.

  7 days

• Plaque index score (Shick R.A., 1961)

  The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = absence of dental plaque on the gingival half of the facial surface of a tooth, 1 = the presence of dental plaque covering less than 1/3 of the gingival half of the farcical surface, 2 = the presence of dental plaque covering 1/3 or less than 2/3 of the gingival half of the facial surface, 3 = the presence of dental plaque covering 2/3 or more of the facial surface). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.

  0 to 44 days - change from baseline to day 14 and 44 will be measured

• Gingival index score (Löe H, 1967)

  The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 3 (0 = Normal gingiva, 1 = Mild inflammation -- slight change in color, slight edema. No bleeding on probing, 2 = Moderate inflammation-redness, edema and glazing. Bleeding on probing, 3 = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding). A mean score of each time point (day 0, 14, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.

  0 to 44 days - change from baseline to day 14 and 44 will be measured

• Optical Coherence Tomography (OCT) score (Turesky modification of the Quigley-Hein Plaque Index, Ajaharain J, 2014)

  The following teeth and surfaces will be evaluated for plaque: #A/3 buccal, #E/8 facial, #J/14 buccal, #K/19 lingual, #O/24 facial, and #T/30 lingual. At day 0, 14 and 44 (± 14 days), units on a scale 0 - 5 (0 = No plaque, 1 = Separate flecks of plaque at the cervical margin, 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin, 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth, 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth, 5 = Plaque covering 2/3 or more of the side of the crown of the tooth). A mean score of each time point (day 0, 7, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.

  0 to 44 days - change from baseline to day 14 and 44 will be measured

Study Arms (2)

Livionex® Dental Gel

EXPERIMENTAL

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.

Drug: Livionex® Dental Gel; Device: Kolibree Toothbrush

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

ACTIVE COMPARATOR

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.

Drug: PreviDent 5000 plus/Tom's of Maine Children's toothpaste; Device: Kolibree Toothbrush

Interventions

Livionex® Dental Gel DRUG

Oral application Dental Plaque, Gingivitis and Oral Microbiome Control.

Also known as: Edathamil

Livionex® Dental Gel

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

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

Also known as: Over the counter toothpaste

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

Kolibree Toothbrush DEVICE

Electric Toothbrush

Livionex® Dental Gel; PreviDent 5000 plus/Tom's of Maine Children's toothpaste

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis; Bacterial Infections

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Pamela Den Besten, DDS, MS

  School of Dentistry, UC San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: December 1, 2015
• Study Start: July 28, 2016
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)