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Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

NCT04368533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • Plaque, Dental
  • Caries, Dental
  • Oral Hygiene

Interventions

DRUG

Livionex Dental Gel

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

DRUG

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 up to 12 months.

Sponsors & Collaborators

Principal Investigators

  • Pamela Den-Besten, DDS, MS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-08
Primary Completion
2020-08-21
Completion
2020-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368533 on ClinicalTrials.gov