NCT00703001

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 6, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

June 19, 2008

Last Update Submit

September 3, 2010

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Improved oral health status of subjects as measured by caries index

    1 year

Study Arms (2)

1--Educational Intervention

ACTIVE COMPARATOR

Students in this arm will receive several in-class educational modules on basic oral health topics.

Behavioral: Educational Intervention

2--Referral intervention

ACTIVE COMPARATOR

Parents of student subjects will receive assistance in accessing oral health care for their child

Behavioral: Referral Intervention

Interventions

Educational InterventionBEHAVIORAL

students in this arm will receive several oral health educational modules in class

1--Educational Intervention
Referral InterventionBEHAVIORAL

Parents of enrolled children will receive assistance in accessing oral health care for their child

2--Referral intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • rd grade student (school year 2007-2008) in one of 9 selected Waukesha School District schools serving a population with high poverty rates

You may not qualify if:

  • cognitive delay that would prohibit student from giving meaningful assent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Kenneth G Schellhase, MD MPH

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 6, 2010

Record last verified: 2010-09

Locations

US(1)