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Oral Health Care Early Intervention Project

Oral Health Care Early Intervention Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00793507
Enrollment
1178
Registered
2008-11-19
Start date
2008-11-30
Completion date
2011-04-30
Last updated
2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries

Keywords

childhood caries

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.

Interventions

OTHEROral 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.

Sponsors

Delta Dental Foundation
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
New ECC*(presence/absence)At end of study, 24 months

Secondary

MeasureTime frame
Association of ECC with perceived barriers to accessing a dental provider.Day 1 of entry into study
Changes in parental knowledge, attitude, beliefs and barriers from pre- to post-studyAt end of study, 24 months
Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert itemsDay 1 of entry into study
Severity of caries( presence/absence of S-ECC)At end of study, 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026