- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327507
Everybody Brush: A Community-wide Toothpaste Distribution Campaign
December 29, 2014 updated by: Advantage Dental Services, LLC
Bending the Oregon Health Plan (OHP) Dentistry Cost Curve in Central Oregon by Reducing the Burden of Oral Disease
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
21731
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
-
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Oregon
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Redmond, Oregon, United States, 97756
- Advantage Dental Services, LLC
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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
6 months to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Family speaks English or Spanish
Exclusion Criteria:
- None
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
Cohorts and Interventions
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.
|
Mailed toothpaste, messages and telephone support.
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Toothpaste only
A tool kit with toothpaste and toothbrushes for the whole family along with oral hygiene instructions will be mailed every three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
increased twice-a-day toothbrushing Toothbrushing
Time Frame: 1 year
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Parent reported toothbrushing frequency for child
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction
Time Frame: 1 year
|
Dental Satisfaction Questionnaire
|
1 year
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Cost
Time Frame: 1 year
|
Per member per month cost of care
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter M Milgrom, DDS, University of Washington
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.
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
June 1, 2014
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
December 23, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 30, 2014
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Advantage001
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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