Summary

Eligibility
for people ages 9 months to 6 years (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Pamela Den-Besten, DDS, MS (ucsf)

Description

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 Aquafresh Kid's toothpaste in reducing dental plaque and caries in healthy and well children every 3 months for 9 months.

Official Title

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

Details

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 (Aquafresh). 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.

Keywords

Plaque, Dental Caries, Dental Oral Hygiene Livionex dental gel, toothpaste Dental Caries Dental Plaque Livionex Dental Gel Aquafresh Kid's toothpaste

Eligibility

You can join if…

Open to people ages 9 months to 6 years

  • 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.

You CAN'T join if...

  • Parents are unable to understand or participate in study procedures.
  • Known allergy to edathamil or known allergy to multiple hygiene and cosmetic products.

Location

  • UCSF Pediatric Dentistry Parnassus Clinic accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04368533
Study Type
Interventional
Last Updated