Dental CariesNCT02327507
Everybody Brush: A Community-wide Toothpaste Distribution Campaign
An observational study of Dental Caries, run by Advantage Dental Services, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Toothpaste & Telephone Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 21,731 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents enrolled in Medcaid OHP and assigned to Advantage Dental Services in Oregon in Crook, Deschutes, or Jefferson counties
Who may be able to join
- Family speaks English or Spanish
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Advantage Dental Services, LLC
Redmond, Oregon, 97756
About this study
Official title: 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
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Toothpaste & Telephone Support
- Keywords
- children, fluoridated toothpaste, health education, Medicaid
- Medical subject headings
- Dental Caries, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste & Telephone SupportBehavioural
Mailed toothpaste, messages and telephone support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased twice-a-day toothbrushing Toothbrushing
Parent reported toothbrushing frequency for child
Measured: 1 year
Secondary outcomes (2)
Satisfaction
Dental Satisfaction Questionnaire
Measured: 1 year
Cost
Per member per month cost of care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21,731 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advantage Dental Services, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter M Milgrom, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327507
- Sponsor's protocol ID
- Advantage001
- Status last verified
- Dec 2014
- First submitted
- 23 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26002091
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bending the Oregon Health Plan (OHP) Dentistry Cost Curve in Central Oregon by Reducing the Burden of Oral Disease
- ClinicalTrials.gov ID
- NCT02327507
- Acronym / sponsor ID
- Advantage001
- Conditions
- Dental Caries
- Keywords
- children, fluoridated toothpaste, health education, Medicaid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,731 participants (estimated)
- Lead sponsor
- Advantage Dental Services, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste & Telephone Support | – | Behavioral: Toothpaste & Telephone SupportA 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. |
| Toothpaste only | – | –A tool kit with toothpaste and toothbrushes for the whole family along with oral hygiene instructions will be mailed every three months |
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents enrolled in Medcaid OHP and assigned to Advantage Dental Services in Oregon in Crook, Deschutes, or Jefferson counties
Key inclusion criteria (1 listed)
- Family speaks English or Spanish
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste & Telephone SupportMailed toothpaste, messages and telephone support. | Behavioural | Toothpaste & Telephone Support |
Primary outcome
increased twice-a-day toothbrushing Toothbrushing
Time frame: 1 year
Parent reported toothbrushing frequency for child
2 secondary outcomes
Satisfaction
Time frame: 1 year
Cost
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 26002091Cunha-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Milgrom, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Advantage Dental Services, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increased twice-a-day toothbrushing Toothbrushing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.