Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Everybody Brush: A Community-wide Toothpaste Distribution Campaign

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02327507
Recruitment Status : Unknown
Verified December 2014 by Advantage Dental Services, LLC.
Recruitment status was:  Active, not recruiting
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Advantage Dental Services, LLC

Brief Summary:
Dental caries (tooth decay) is a disease with significant public health implications afflicting low-income children, with marked rural disparities in disease prevalence and treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties have experienced tooth decay. Effective approaches to prevent decay include brushing with fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet <50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with parental education can increase toothbrushing frequency and reducing tooth decay. However, many parents are confused about when to start, how much and often toothpaste should be used, and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older children to brush their own. The investigators' objective is to implement and evaluate a community-wide toothpaste distribution campaign enhanced by telephone support for OHP children and adolescents and their families in Central Oregon

Condition or disease Intervention/treatment
Dental Caries Behavioral: Toothpaste & Telephone Support

Detailed Description:
A community-wide toothpaste distribution campaign enhanced by telephone support. A tooth kit with toothpaste and toothbrushes for the whole family together with oral hygiene instructions in English and Spanish will be mailed every 3 months. Half of the population will be randomly assigned to also receive telephone support (Short message service and one-to-one calls). Families will receive biweekly messages with oral hygiene tips. Bilingual culturally competent staff will be available by telephone to support families in overcoming barriers.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 21731 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bending the Oregon Health Plan (OHP) Dentistry Cost Curve in Central Oregon by Reducing the Burden of Oral Disease
Study Start Date : June 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Toothpaste & Telephone Support
A tool kit with toothpaste and toothbrushes for the whole family along with oral hygiene instructions in both English and Spanish will be mailed to the homes of all OHP children and adolescents every three months. Half the populations will be assigned to also receive telephone support.
Behavioral: Toothpaste & Telephone Support
Mailed toothpaste, messages and telephone support.

Toothpaste only
A tool kit with toothpaste and toothbrushes for the whole family along with oral hygiene instructions will be mailed every three months



Primary Outcome Measures :
  1. increased twice-a-day toothbrushing Toothbrushing [ Time Frame: 1 year ]
    Parent reported toothbrushing frequency for child


Secondary Outcome Measures :
  1. Satisfaction [ Time Frame: 1 year ]
    Dental Satisfaction Questionnaire

  2. Cost [ Time Frame: 1 year ]
    Per member per month cost of care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents enrolled in Medcaid OHP and assigned to Advantage Dental Services in Oregon in Crook, Deschutes, or Jefferson counties
Criteria

Inclusion Criteria:

  • Family speaks English or Spanish

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327507


Locations
Layout table for location information
United States, Oregon
Advantage Dental Services, LLC
Redmond, Oregon, United States, 97756
Sponsors and Collaborators
Advantage Dental Services, LLC
Investigators
Layout table for investigator information
Principal Investigator: Peter M Milgrom, DDS University of Washington

Layout table for additonal information
Responsible Party: Advantage Dental Services, LLC
ClinicalTrials.gov Identifier: NCT02327507     History of Changes
Other Study ID Numbers: Advantage001
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Advantage Dental Services, LLC:
children
fluoridated toothpaste
health education
Medicaid

Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases