Clinical Trial: Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Adherence to oral hygiene [ Time Frame: 7 days ]
    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.
  • Plaque index score (Shick R.A., 1961) [ Time Frame: 0 to 44 days - change from baseline to day 7 and 44 will be measured ]
    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, 7 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, 7, and 44) will be compared (t-test) for each patient longitudinally and between the treatment and the control group.
  • Gingival index score (Löe H, 1967) [ Time Frame: 0 to 44 days - change from baseline to day 7 and 44 will be measured ]
    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, 7 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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of California, San Francisco

    Dates:
    Date Received: November 6, 2015
    Date Started: June 2016
    Date Completion: June 2018
    Last Updated: November 28, 2016
    Last Verified: November 2016