CompletedPhase 1

Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

United States78 participantsStarted 2019-02-08

Plain-language 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 up to 12 months.

Who can participate

Age range9 Months – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Changes of dental plaque

Timeframe: up to 12 months

Incidence of new dental caries.

Timeframe: up to 12 months

Changes of oral microbiome composition

Timeframe: up to 12 months

Trial details

NCT IDNCT04368533

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-21

View on ClinicalTrials.gov More Plaque, Dental trials