Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children

April 22, 2022 updated by: University of California, San Francisco

A Pilot Study to Evaluate the Effect of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Pediatric Dentistry Parnassus Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Livionex Dental Gel
Children assigned to this arm will brush/clean teeth with Livionex Dental Gel twice a day for up to 12 months.They 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. Data on compliance and side-effects of toothpastes will be collected at each of the calls.
Other: Livionex Dental Gel
The subjects will brush their teeth with Livionex Dental Gel twice a day for up to 12 months.
ACTIVE_COMPARATOR: A standard children's toothpaste containing 1500 ppm fluoride
Children assigned to this arm will brush/clean teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for up to 12 months. They 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, 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 at 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
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.
up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Pamela Den-Besten, DDS, MS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2019

Primary Completion (ACTUAL)

August 21, 2020

Study Completion (ACTUAL)

August 21, 2020

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

April 27, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-22447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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