Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02617407
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pamela Den Besten, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Other: Livionex® Dental Gel Other: PreviDent 5000 plus/Tom's of Maine Children's toothpaste Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Pilot Study -- Oral Microbiome and Dental Plaque Control With Livionex(R) in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Livionex® Dental Gel
Dental Plaque, Gingivitis and Oral Microbiome Control.

Active Comparator: 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.
Other: PreviDent 5000 plus/Tom's of Maine Children's toothpaste
Dental Plaque, Gingivitis and Oral Microbiome Control.




Primary Outcome Measures :
  1. 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.

  2. Plaque index score (Shick R.A., 1961) [ Time Frame: 0 to 44 days - change from baseline to day 14 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, 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.

  3. Gingival index score (Löe H, 1967) [ Time Frame: 0 to 44 days - change from baseline to day 14 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, 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.

  4. Optical Coherence Tomography (OCT) score (Turesky modification of the Quigley-Hein Plaque Index, Ajaharain J, 2014) [ Time Frame: 0 to 44 days - change from baseline to day 14 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, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617407


Contacts
Layout table for location contacts
Contact: Ying Lu, PhD 415-476-3833 ying.lu@ucsf.edu

Locations
Layout table for location information
United States, California
University of California Recruiting
San Francisco, California, United States, 94115
Contact: Pamela Den-Besten, DDS    415-502-6383    Pamela.DenBesten@ucsf.edu   
Contact: Ying Lu, PhD    415-476-3833    ying.lu@ucsf.edu   
Sub-Investigator: Lee Ann Baxter-Lowe, Ph.D.         
Principal Investigator: Pamela Den-Besten, DDS, MS         
Sub-Investigator: Ling Zhan, DDS, PhD         
Sub-Investigator: Jeremy Horst, DDS, PhD         
Sub-Investigator: Petra Wilder-Smith, DDS, PhD         
Sub-Investigator: Alexis Melton, MD         
Sub-Investigator: Lynn Ramirez, MD         
Sub-Investigator: Christopher Dvorak, MD         
Sub-Investigator: Robert Goldsby, MD         
Sub-Investigator: Ying Lu, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Pamela Den Besten, DDS, MS School of Dentistry, UC San Francisco

Publications of Results:

Other Publications:
Richard A. Shick and Major M. Ash Jr. Evaluation of the Vertical Method of Toothbrushing. Journal of Periodontology October 1961, Vol. 32, No. 4: 346-353.

Layout table for additonal information
Responsible Party: Pamela Den Besten, DDS, UCSF School of Dentistry Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02617407     History of Changes
Other Study ID Numbers: 15-18297
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Keywords provided by Pamela Den Besten, University of California, San Francisco:
Dental Plaque
Gingivitis
Bacterial Infection
Oral Hygiene
HSCT
Oral Microbiome
Gut Microbiome
Blood Microbiome

Additional relevant MeSH terms:
Layout table for MeSH terms
Listerine
Sodium Fluoride
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents