Clinical trial NCT02327507: Everybody Brush: A Community-wide Toothpaste Distribution Campaign
Official title: Bending the Oregon Health Plan (OHP) Dentistry Cost Curve in Central Oregon by Reducing the Burden of Oral Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Keywords: children
fluoridated toothpaste
health education
Medicaid
Lead sponsor: Advantage Dental Services, LLC
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 21731
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: Inclusion Criteria:

* Family speaks English or Spanish

Exclusion Criteria:

* None

Primary outcomes:
measure: increased twice-a-day toothbrushing Toothbrushing
timeFrame: 1 year
Secondary outcomes:
measure: Satisfaction
timeFrame: 1 year
measure: Cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Redmond
country: United States
facility: Advantage Dental Services, LLC
state: Oregon
Study officials:
affiliation: University of Washington
name: Peter M Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.