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Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

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ClinicalTrials.gov Identifier: NCT04368533
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is an investigator initiated randomized double-blind pilot study at the UCSF Pediatric Dental Clinics to compare effectiveness of a new toothpaste Livionex Dental Gel with a standard children's toothpaste containing 1500 ppm fluoride in reducing dental plaque and caries in healthy and well children every 3 months for 9 months.

Condition or disease Intervention/treatment Phase
Plaque, Dental Caries, Dental Oral Hygiene Other: Livionex Dental Gel Other: A standard children's toothpaste containing 1500 ppm fluoride Not Applicable

Detailed Description:

Dental plaque is the primary etiological factor in the initiation of caries, gingival inflammation and subsequent destruction of periodontal tissues. Effective oral hygiene eliminates microbial plaque leading to resolution of gingival inflammation. Livionex Dental Gel is a toothpaste that is effective in reducing plaque in adults while not containing the additives found in other toothpastes that can cause increased gingival irritation. The investigators hypothesize that brushing with Livionex toothpaste creates an oral environment that prevents dental plaque accumulation and promotes oral health in children.

This study will prospectively enroll 70 children aged 9 months to 6 years from UCSF affiliated pediatrics or pediatric dental clinics. Upon obtaining an informed consent, children will be randomized in a 1:1 ratio to the use of test (Livionex Dental Gel) and control toothpaste (a standard children's toothpaste containing 1500 ppm fluoride ). All patients will be provided a soft brush at enrollment, and the child and/or the parent will be taught to brush/clean after the first exam, with the assigned dentifrice, at the study center before they go home. Additionally, each subject will receive a new brush at every 3-month visit. Subjects will undergo a dental exam by a trained dentist including caries assessment (at baseline, 1, 3, 6 and 9 months), dental plaque photograph, (at baseline, 1, 3, 6 and 9 months), and swab samples for dental plaque and saliva will be collected at all study visits. A questionnaire will be given to address dentifrice and brushing experience at monthly phone call and each study visit. A monthly phone call will be made to assess compliance with the study protocol, and to answer any questions or concerns. Data on compliance and side effects of toothpastes will be collected at each of the calls.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Livionex Dental Gel
Children assigned to this arm will brush/clean teeth with Livionex Dental Gel twice a day for 9 months.They will undergo a dental exam by a trained dentist including caries assessment (at baseline, 1, 3, 6, and 9 months), dental plaque photograph, (at baseline, 1, 3, 6 and 9 months), and swab samples for dental plaque and saliva will be collected at all study visits. A questionnaire will be given to address dentifrice and brushing experience at each study visit. A monthly phone call will be made to assess compliance with the study protocol, and to answer any questions or concerns. Data on compliance and side-effects of toothpastes will be collected at each of the calls.
Other: Livionex Dental Gel
The subjects will brush their teeth with Livionex Dental Gel twice a day for 9 months.

Active Comparator: A standard children's toothpaste containing 1500 ppm fluoride
Children assigned to this arm will brush/clean teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for 9 months. They will undergo a dental exam by a trained dentist including caries assessment (at baseline, 1, 3, 6, and 9 months), dental plaque photograph, (at baseline, 1, 3, 6 and 9 months), and swab samples for dental plaque and saliva will be collected at all study visits. A questionnaire will be given to address dentifrice and brushing experience at each study visit. A monthly phone call will be made to assess compliance with the study protocol, and to answer any questions or concerns. Data on compliance and side-effects of toothpastes will be collected at each of the calls.
Other: A standard children's toothpaste containing 1500 ppm fluoride
The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for 9 months.




Primary Outcome Measures :
  1. Changes of dental plaque [ Time Frame: up to 9 months ]
    To compare plaque reduction between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9 months. Plaque will be assessed using a plaque index score (Turesky modification of the Quigley-Hein Plaque Index) for each tooth and a total plaque score will be divided by the number of teeth present for analysis.

  2. Incidence of new dental caries. [ Time Frame: up to 9 months ]
    To compare incidence of new dental caries between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9 months.

  3. Changes of oral microbiome composition [ Time Frame: up to 9 months ]
    Using 16S rRNA gene sequences and taxonomic annotation to identify dental caries relevant pathogenic, commensal, and probiotic bacteria and archaea and to compare temporal changes in oral microbiome composition, diversity and relative quantity between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9 months.



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Ages Eligible for Study:   9 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children aged 9 months to 6 years.
  • Parent and children are able complete the study procedures.
  • Parent/legal guardian willing to allow their child participate and sign informed consent form.

Exclusion Criteria:

  • Parents are 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): NCT04368533


Contacts
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Contact: Ying Lu, PhD 415-476-3833 ying.lu@ucsf.edu

Locations
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United States, California
UCSF Pediatric Dentistry Parnassus Clinic Recruiting
San Francisco, California, United States, 94143
Contact: Janelle Urata, RDH, MS    415-476-9287    janelle.urata@ucsf.edu   
Contact: Ying Lu, PhD    415-476-3833    ying.lu@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Pamela Den-Besten, DDS, MS University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04368533    
Other Study ID Numbers: 17-22447
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Livionex dental gel, toothpaste
Additional relevant MeSH terms:
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Dental Caries
Dental Plaque
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Dental Deposits
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs