Oral Health Care Early Intervention Project - Full Text View

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center Delta Dental Foundation of Colorado
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00793507

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 Incidence	Other: Oral Health Care Early Intervention Project

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Oral Health Care Early Intervention Project

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

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 ]

Estimated Enrollment:	1200
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Intervention Group: Experimental 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.
2: Control Group: Active Comparator 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.

Arms

Assigned Interventions

1: Intervention Group: Experimental

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.

2: Control Group: Active Comparator

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:

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:

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.
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.
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:

0 - 36 months;
Have at least one tooth;
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:

No teeth; in essence child has not had any teeth erupt yet;
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
Reports receiving primary health care somewhere else other than at one of the study practices;
Parents < 18 years of age.

Contacts and Locations

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

Contacts

Contact: Matthew F. Daley, MD	303-724-1079	daley.matthew@tchden.org
Contact: Patricia Shobe, MPH	303-724-0408	patricia.shobe@ucdenver.edu

Locations

United States, Colorado
Salud Family Health Centers	Recruiting
Ft. Collins, Colorado, United States, 80524
Contact: Maria de Jesus 720-322-9417
Rocky Mountain Youth	Recruiting
Aurora, Colorado, United States, 80011
Contact: Joe Craig, MD 303-869-2173 Joe.Craig@UCHSC.edu
Rocky Mountain Youth	Not yet recruiting
Thornton, Colorado, United States, 80229
Contact: Joe Craig, MD 303-869-2173 Joe.Craig@UCHSC.edu
Grand Mesa Dental Hygiene, LLC	Not yet recruiting
Delta, Colorado, United States, 81416
Contact: Mary Vigil, RDH 970-874-3801
The Pediatric Associates	Not yet recruiting
Montrose, Colorado, United States, 81401
Contact: Amber Hickert 970-249-2421

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Delta Dental Foundation 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:

Beltrán-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.

Yu SM, Bellamy HA, Kogan MD, Dunbar JL, Schwalberg RH, Schuster MA. Factors that influence receipt of recommended preventive pediatric health and dental care. Pediatrics. 2002 Dec;110(6):e73.

Kenney GM, McFeeters JR, Yee JY. Preventive dental care and unmet dental needs among low-income children. Am J Public Health. 2005 Aug;95(8):1360-6.

Liu J, Probst JC, Martin AB, Wang JY, Salinas CF. Disparities in dental insurance coverage and dental care among US children: the National Survey of Children's Health. Pediatrics. 2007 Feb;119 Suppl 1:S12-21.

Edelstein BL. Disparities in oral health and access to care: findings of national surveys. Ambul Pediatr. 2002 Mar-Apr;2(2 Suppl):141-7. Review.

Lewis CW, Johnston BD, Linsenmeyar KA, Williams A, Mouradian W. Preventive dental care for children in the United States: a national perspective. Pediatrics. 2007 Mar;119(3):e544-53.

dela Cruz GG, Rozier RG, Slade G. Dental screening and referral of young children by pediatric primary care providers. Pediatrics. 2004 Nov;114(5):e642-52.

Lewis CW, Grossman DC, Domoto PK, Deyo RA. The role of the pediatrician in the oral health of children: A national survey. Pediatrics. 2000 Dec;106(6):E84.

Mofidi M, Rozier RG, King RS. Problems with access to dental care for Medicaid-insured children: what caregivers think. Am J Public Health. 2002 Jan;92(1):53-8.

Siegal MD, Marx ML, Cole SL. Parent or caregiver, staff, and dentist perspectives on access to dental care issues for head start children in Ohio. Am J Public Health. 2005 Aug;95(8):1352-9. Epub 2005 Jul 7.

Kelly SE, Binkley CJ, Neace WP, Gale BS. Barriers to care-seeking for children's oral health among low-income caregivers. Am J Public Health. 2005 Aug;95(8):1345-51.

Finlayson TL, Siefert K, Ismail AI, Delva J, Sohn W. Reliability and validity of brief measures of oral health-related knowledge, fatalism, and self-efficacy in mothers of African American children. Pediatr Dent. 2005 Sep-Oct;27(5):422-8.

American Academy of Pediatric Dentistry; American Academy of Pediatrics; American Academy of Pediatric Dentistry Council on Clinical Affairs. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2005-2006;27(7 Suppl):31-3. No abstract available.

Truman BI, Gooch BF, Sulemana I, Gift HC, Horowitz AM, Evans CA, Griffin SO, Carande-Kulis VG; Task Force on Community Preventive Services. Reviews of evidence on interventions to prevent dental caries, oral and pharyngeal cancers, and sports-related craniofacial injuries. Am J Prev Med. 2002 Jul;23(1 Suppl):21-54. Review.

Responsible Party:	University of Colorado Denver ( Matthew F. Daley, MD, Associate Professor )
Study ID Numbers:	PN200703-001, 07-0198
Study First Received:	November 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00793507
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado at Denver and Health Sciences Center:

childhood caries

Study placed in the following topic categories:

Dental Caries

ClinicalTrials.gov processed this record on January 15, 2009