Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00703001 |
| Other study ID # |
2007I-45 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 19, 2008 |
| Last updated |
September 3, 2010 |
| Start date |
April 2008 |
| Est. completion date |
April 2010 |
Study information
| Verified date |
September 2010 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The Waukesha Smiles Project will compare approaches to improve oral health habits and
increase access to basic dental care for low-income children in Waukesha, Wisconsin through
a school-based outreach program of oral health promotion, screening and referral.
Description:
A. HYPOTHESIS / SPECIFIC AIMS: The purpose of Waukesha Smiles: Dental Outreach to Low-income
Children will be to improve oral health habits and increase access to primary and preventive
dental care for low-income children in the city of Waukesha.
The typical forms of dental decay seen in children, also called dental "caries," are the
result of a transmissible infectious disease process that is enabled by poor oral hygiene
and dietary choices.1-5 When unchecked, this process leads to pain and tooth loss, which can
in turn lead to disfigurement, self-esteem problems, impaired nutrition, and even systemic
disease.3, 6 Access to basic dental care and good oral health habits can reduce preventable
dental disease and these associated outcomes.7 However, poor oral health habits are more
prevalent among children from lower socioeconomic strata.7-9 And limited access to
primary/preventive dental care is common for low income and/or minority children, and
represents a major health risk for these specific populations.9, 10 Self-pay for care is a
major barrier for low-income families.9, 10 Children with Title 19-related dental insurance
(Medicaid) also face similar barriers from limited provider acceptance of this program: due
to low levels of reimbursement many dentists in the Waukesha area limit the number of
Title-19 patients in their practices, and some do not accept this insurance at all.10, 11
Furthermore, adequate access to dental care alone is not sufficient to assure oral health:
regular dental visits cannot compensate for poor oral health habits.
The Waukesha County Dental Clinic (WCDC) will open in January 2008 with a mission to serve
low-income uninsured and underinsured county residents. This new clinic will serve a
critical function in our community. However, despite the increased access to care that the
Waukesha County Dental Clinic will provide, we expect that many eligible low-income Waukesha
children will still not receive needed dental care for a variety of reasons. These include:
lack of awareness of the clinic; persistent concern about financial burdens; lack of
understanding about the benefits of routine dental care; logistical barriers; and language
and cultural barriers. Moreover, we expect that if basic oral health habits could be
improved in Waukesha children, the need for anything but preventive dental care would
diminish.
We hypothesize that an Educational Intervention, consisting of brief monthly classroom
presentations on oral health plus monthly distribution of a new toothbrush and tooth paste,
will lead to improved oral health outcomes among low-income 3rd grade students when compared
to a Referral Intervention wherein children will receive a detailed referral and assistance
finding a dentist after an oral health screening exam. Our primary outcomes are rates of
untreated dental caries, and the proportion of children needing early or urgent dental care.
B. DESIGN/ METHODS: Aim/Objective 1: Assemble a cohesive study team, including parent
advisory board and bilingual study staff for oral health outreach interventions.
Aim/Objective 2: Develop and prepare Educational and Referral Interventions Aim/Objective 3:
Conduct both interventions in two phases, using a cross-over approach so that all children
in the study receive both interventions.
Aim/Objective 4: Evaluate, sustain, and disseminate this partnership for child oral health
improvement.
Waukesha Smiles will compare two different school-based strategies for improving oral health
among 400 3rd grade children in 9 different elementary schools in the city of Waukesha with
high proportions of low-income students. All students will receive screening oral health
exams at the beginning and end of each intervention; parents will be provided with the exam
results and recommendations for care. Intervention groups will divided by school, so that
all children in the same school receive the same intervention (as close to 200 children per
group as feasible). However, to maximize community benefit from this project and allay
concerns about participation in research, we will use a crossover design such that the
schools will swap interventions after the first 12 months (Phase I). Thus Intervention Phase
II will provide the same interventions for the same duration in the opposite schools, again
with pre- and post-intervention oral screening exams.
INTERVENTION PHASE I, First Cohort: Participants in the Referral Intervention arm will
receive a specific referral for dental care as indicated by their baseline exam; detailed
information about the Waukesha County Dental Clinic (WCDC), a new clinic opening to serve
uninsured and low-income county residents; and reminders and active follow-up by study staff
to assist children and parents in overcoming barriers to accessing recommended care.
INTERVENTION PHASE I, Second Cohort:The Educational Intervention arm will consist of monthly
classroom visits by a dental education team (dental hygienist plus assistant) to provide
brief oral health education modules, and to distribute a new toothbrush and new tube of
toothpaste each month. On the first visit, participants will be given a timer to promote
proper brushing duration. In INTERVENTION PHASE II, the first and second cohorts will swap
interventions, allowing all children in the study to receive both interventions.
C. VARIABLES (predictor / outcome; stopping rules / endpoint)
D. STATISTICS: We will use McNemar's test and other basic statistical testing methods to
determine if the results of the pre- and post-intervention oral health assessment exams are
significantly different in terms of the prevalence of our primary outcomes: untreated caries
and the need for early/urgent dental care. Because our groups are not randomized, in order
to directly compare differences in outcomes between interventions (Referral vs. Education)
we will construct a logistic regression model to allow adjustment for multiple baseline
differences between groups; variables in the model will include school attended, low-income
status, and parental education level. Using descriptive statistics we will also analyze (a)
parental surveys for changes in oral health knowledge/attitude/behavior, and changes in
perceived barriers to dental care, (b) rates of follow-through on recommended dental care,
and (c) rates of Emergency Department visits at two local hospitals for pediatric dental
problems with patient zip codes lying in our schools' catchment area. We will not seek to
track Emergency visits by patient name. Family Medicine residents' experiences with the
project will be evaluated through their rotations. Lastly, through feedback given to the
study team, community partners, and investigators, we will seek to determine the feasibility
of sustaining one or both of these interventions in Waukesha schools, and to determine how
best to disseminate our results to others.
E. RISKS: We believe the risks in this study are relatively minimal, and will include:
1. possible embarrassment of the child due to identification of dental needs during oral
health assessment
2. unable to receive recommended dental care despite assistance with referrals,
availability of new clinic catering to low-income and Medicaid patients, etc.
3. transmission of infection during oral health assessment
4. breech of confidentiality
F. BENEFITS: This project will expand on and sustain the success of a 2004 HWPP planning
grant ("Creating a Community-Academic Partnership to Improve the Oral Health of Waukesha
County"). This ongoing partnership led to the development of the Waukesha County Dental
Clinic to address unmet oral health needs. This success is evidence of a productive working
relationship and long-term commitment of financial and professional resources from each
partner according to their particular strengths. This productive partnership will continue
to meet at least biweekly during this project, and demonstrates commitment and ability to
attain the elements of the Community-Academic Partnership Model such as realistic assessment
of needs/barriers, ability to garner broad support, shared passion for improving oral
health, creating and attaining measurable goals, mutual trust, and sharing resources.
We will measure the impact of this project through several key outcomes. At the end of the
each intervention period, we will analyze interval differences in the oral health screening
exam results for each study arm; specific attention will be paid to differences between
groups in rates of untreated caries, appearance of new interval lesions, and regression of
early lesions. We will measure the proportion of children requiring early or urgent dental
care. We will also track the outcomes of referrals to the WCDC, and pediatric Emergency
Department visits for acute dental problems at local hospitals using zip code methods. To
maximize the health impact of this project, we will develop a how-to manual and resource
guide of best practices that will allow other Wisconsin communities to take this program
"off the shelf." In addition, family medicine residents will take lessons learned back to
the underserved areas where they tend to practice.
