NCT02327507

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,731

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

December 23, 2014

Last Update Submit

December 29, 2014

Conditions

Keywords

childrenfluoridated toothpastehealth educationMedicaid

Outcome Measures

Primary Outcomes (1)

  • increased twice-a-day toothbrushing Toothbrushing

    Parent reported toothbrushing frequency for child

    1 year

Secondary Outcomes (2)

  • Satisfaction

    1 year

  • Cost

    1 year

Study Arms (2)

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

Toothpaste only

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

Interventions

Mailed toothpaste, messages and telephone support.

Toothpaste & Telephone Support

Eligibility Criteria

Age6 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Family speaks English or Spanish

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advantage Dental Services, LLC

Redmond, Oregon, 97756, United States

Location

Related Publications (1)

  • Cunha-Cruz J, Milgrom P, Shirtcliff RM, Huebner CE, Ludwig S, Allen G, Scott J. "Everybody brush!": protocol for a parallel-group randomized controlled trial of a family-focused primary prevention program with distribution of oral hygiene products and education to increase frequency of toothbrushing. JMIR Res Protoc. 2015 May 22;4(2):e58. doi: 10.2196/resprot.4485.

MeSH Terms

Conditions

Dental CariesHealth Education

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

DentifricesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Peter M Milgrom, DDS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 30, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations