Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    70
  • sponsor
    University of California, San Francisco
Updated on 26 January 2021
fluoride
dental plaque

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.

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.

Details
Condition Dental Plaque, Dental caries, Oral Hygiene, cavities, cavity, caries, tooth decay
Treatment Livionex Dental Gel, Aquafresh Kid's toothpaste, A standard children's toothpaste containing 1500 ppm fluoride
Clinical Study IdentifierNCT04368533
SponsorUniversity of California, San Francisco
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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