Oral Health Care Early Intervention Project
Recruitment status was Recruiting
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First Received Date ICMJE | November 17, 2008 | ||||||||
Last Updated Date | January 5, 2009 | ||||||||
Start Date ICMJE | November 2008 | ||||||||
Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
New ECC*(presence/absence) [ Time Frame: At end of study, 24 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00793507 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Oral Health Care Early Intervention Project | ||||||||
Official Title ICMJE | Oral Health Care Early Intervention Project | ||||||||
Brief Summary | This pilot project consists of co-locating dental hygienist services in medical primary care offices. Dental hygienists will work in close collaboration with the primary care offices, providing preventive dental care to young children either before or after scheduled well-child visits. |
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Detailed Description | This investigation is designed to determine the effect of having co-located dental hygienists in primary care offices on the incidence of early childhood caries among young children seen at these primary care offices. The dental hygienists will provide routine preventive dental care and oral health education within the usual scope of their practice. The study is also designed to assess parent knowledge, attitudes, and beliefs about oral health and perceived barriers to preventive dental care, as well as how their oral health-related attitudes change over time. The specific aims for this project are: SA1: Among parents of young children seen in pediatric and family medicine primary care practices, determine the knowledge, attitudes, and beliefs of parents regarding the importance of oral health, means of preventing caries, and perceived barriers to accessing regular preventive dental care. SA2: After co-locating dental hygienists within pediatric and family medicine primary care practices, determine by randomized controlled trial the effect of routine preventive dental care provided by dental hygienists on the incidence of early childhood caries. SA#: Among parents of young children seen in pediatric and family medicine primary care practices, determine how parental oral health-related knowledge, attitudes, beliefs, and perceived barriers change over time, among parents of children seen by a co-located dental hygienist. The major hypotheses for this project are:
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Caries Incidence | ||||||||
Intervention ICMJE | Other: Oral Health Care Early Intervention Project
The intervention group will receive routine preventive dental care, 2 to 4 times per year depending on risk of caries. The intervention group will also receive pre-scheduling, reminders, and care coordination by the dental hygienist. The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. In order to determine the incidence of early childhood caries at study enrollment, both intervention and control groups will receive a standardized oral examination with an assessment of caries presence and extent on the day of enrollment, at 12 months and at 24 months after enrollment. Both children in the control group and intervention group will be referred to a dentist if found to need restorative care. |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 1200 | ||||||||
Estimated Completion Date | April 2011 | ||||||||
Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Children with the following characteristics will be included in the study:
Exclusion Criteria: Children with the following characteristics will be excluded from the study:
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Gender | Both | ||||||||
Ages | up to 36 Months | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00793507 | ||||||||
Other Study ID Numbers ICMJE | PN200703-001, 07-0198 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Matthew F. Daley, MD, Associate Professor, University of Colorado Denver | ||||||||
Study Sponsor ICMJE | University of Colorado, Denver | ||||||||
Collaborators ICMJE | Delta Dental Foundation of Colorado | ||||||||
Investigators ICMJE |
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Information Provided By | University of Colorado, Denver | ||||||||
Verification Date | January 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |