Clinical trial NCT00793507: Oral Health Care Early Intervention Project
Official title: Oral Health Care Early Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Keywords: childhood caries
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Delta Dental Foundation
First posted: 2008-11-19
Enrollment: 1178
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

Specific Aim 1: 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.

Specific Aim 2: 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.

Specific Aim 3: 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:

1. Parents of children with public health insurance (Medicaid or Child Health Plan-Plus) will have one-half the odds of reporting a usual source of preventive dental care compared to children with private health insurance.
2. Among young children receiving routine preventive dental care by a co-located dental hygienist, 10% will develop dental caries over a 24-month period, compared with 20% caries experience among children who do not receive routine preventive dental care by a co-located dental hygienist.
3. Parents of children with early childhood caries (any caries in a primary tooth) which developed over a 24-month period will have more than twice the odds of reporting barriers to accessing a dental provider than parents of children with no early childhood caries.

Eligibility criteria: Inclusion Criteria:

Children with the following characteristics will be included in the study:

1. 0 - 36 months;
2. Have at least one tooth;
3. Have had one or more visits to a study practice in the prior 18 months.

Exclusion Criteria:

Children with the following characteristics will be excluded from the study:

1. No teeth; in essence child has not had any teeth erupt yet;
2. Chronic medical condition affecting oral health or the ability to perform routine preventive dental care, such as cerebral palsy, mental retardation, ectodermal dysplasia, and other genetic syndromes affecting oral health
3. Reports receiving primary health care somewhere else other than at one of the study practices;
4. Parents \< 18 years of age.

Primary outcomes:
measure: New ECC*(presence/absence)
timeFrame: At end of study, 24 months
Secondary outcomes:
measure: Association of ECC with perceived barriers to accessing a dental provider.
timeFrame: Day 1 of entry into study
measure: Changes in parental knowledge, attitude, beliefs and barriers from pre- to post-study
timeFrame: At end of study, 24 months
measure: Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert items
timeFrame: Day 1 of entry into study
measure: Severity of caries( presence/absence of S-ECC)
timeFrame: At end of study, 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Youth
state: Colorado
city: Delta
country: United States
facility: Grand Mesa Dental Hygiene, LLC
state: Colorado
city: Ft. Collins
country: United States
facility: Salud Family Health Centers
state: Colorado
city: Montrose
country: United States
facility: The Pediatric Associates
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Youth
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Matthew F. Daley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Patricia Braun, MD
role: STUDY_DIRECTOR
References:
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