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NCT Number: NCT04368533

Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

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 up to 12 months.

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Key information

Conditions

Plaque, Dental Caries, Dental Dental Caries Dental Deposits Dental Plaque Oral Hygiene Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

9 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCSF Pediatric Dentistry Parnassus Clinic

San Francisco, California, 94143, United States

About this study

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 78 children aged 9 months to 12 years from UCSF 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, 9 or 12 months), dental plaque photograph, (at baseline, 1, 3, 6 and 9 or 12 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 in a phone call one month after enrollment and at the last study visit. Data on compliance and side effects of toothpastes will be collected at each of the calls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children aged 9 months to 12 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.

Treatment and study plan

Livionex Dental Gel

Drug

The subjects will brush their teeth with Livionex Dental Gel twice a day for up to 12 months.

A standard children's toothpaste containing 1500 ppm fluoride

Drug

The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months.

Primary outcomes

  1. Changes of dental plaque

    Time frame: up to 12 months

    To compare plaque reduction between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months 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 12 months

    To compare incidence of new dental caries between Livionex Dental Gel and control toothpaste group from baseline to 1, 3, 6 and 9/12 months.

  3. Changes of oral microbiome composition

    Time frame: up to 12 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 9/12 months months.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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