Oral Health Care Early Intervention Project

This study has been completed.
Sponsor:
Collaborator:
Delta Dental of Colorado
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00793507
First received: November 17, 2008
Last updated: February 4, 2013
Last verified: January 2009
  Purpose

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.


Condition Intervention
Caries
Other: Oral Health Care Early Intervention Project

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oral Health Care Early Intervention Project

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • New ECC*(presence/absence) [ Time Frame: At end of study, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of ECC with perceived barriers to accessing a dental provider. [ Time Frame: Day 1 of entry into study ] [ Designated as safety issue: No ]
  • Changes in parental knowledge, attitude, beliefs and barriers from pre- to post-study [ Time Frame: At end of study, 24 months ] [ Designated as safety issue: No ]
  • Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert items [ Time Frame: Day 1 of entry into study ] [ Designated as safety issue: No ]
  • Severity of caries( presence/absence of S-ECC) [ Time Frame: At end of study, 24 months ] [ Designated as safety issue: No ]

Enrollment: 1178
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Intervention Group
All participants in the intervention group will be receiving standard preventive dental care received by children in their dental providers' office. These intervention children will receive dental scaling, cleaning and fluoride varnish at visits every three to six months. All participants in the intervention group will receive active reminder/recall from the hygienist, encouraging the participants to return every three to six months for the oral exam, cleaning, scaling and fluoride application.
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.
Active Comparator: 2: Control Group
The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist.
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.

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

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793507

Locations
United States, Colorado
Rocky Mountain Youth
Aurora, Colorado, United States, 80011
Grand Mesa Dental Hygiene, LLC
Delta, Colorado, United States, 81416
Salud Family Health Centers
Ft. Collins, Colorado, United States, 80524
The Pediatric Associates
Montrose, Colorado, United States, 81401
Rocky Mountain Youth
Thornton, Colorado, United States, 80229
Sponsors and Collaborators
University of Colorado, Denver
Delta Dental of Colorado
Investigators
Principal Investigator: Matthew F. Daley, MD University of Colorado, Denver
Study Director: Patricia Braun, MD University of Colorado, Denver
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00793507     History of Changes
Other Study ID Numbers: 07-0198, PN200703-001
Study First Received: November 17, 2008
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
childhood caries

ClinicalTrials.gov processed this record on July 22, 2014