Oral Health Care Early Intervention Project

NCT00793507 | Completed

• 2 other identifiers: 07-0198PN200703-001
• Study Type: interventional
• Target: 1,178
• Locations: 1 country
• Sites: 5

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.

Conditions

Caries

Keywords

childhood caries

Outcome Measures

Primary Outcomes (1)

• New ECC*(presence/absence)

  At end of study, 24 months

Secondary Outcomes (4)

• 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-study

  At end of study, 24 months

• Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert items

  Day 1 of entry into study

• Severity of caries( presence/absence of S-ECC)

  At end of study, 24 months

Study Arms (2)

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

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

Interventions

Oral Health Care Early Intervention Project OTHER

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.

1: Intervention Group; 2: Control Group

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with the following characteristics will be included in the study:
• months;
• Have at least one tooth;
• Have had one or more visits to a study practice in the prior 18 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Delta Dental Foundation: collaborator

Study Sites (5)

Rocky Mountain Youth

Aurora, Colorado, 80011, United States

Location

Grand Mesa Dental Hygiene, LLC

Delta, Colorado, 81416, United States

Location

Salud Family Health Centers

Fort Collins, Colorado, 80524, United States

Location

The Pediatric Associates

Montrose, Colorado, 81401, United States

Location

Rocky Mountain Youth

Thornton, Colorado, 80229, United States

Location

Related Publications (15)

• Beltran-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.

  PMID: 16121123 BACKGROUND

• U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. 1-332. 2000. Rockville, MD, U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health. Ref Type: Report

  BACKGROUND

• 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. doi: 10.1542/peds.110.6.e73.

  PMID: 12456940 BACKGROUND

• 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. doi: 10.2105/AJPH.2004.056523.

  PMID: 16043667 BACKGROUND

• 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. doi: 10.1542/peds.2006-2089D.

  PMID: 17272579 BACKGROUND

• Edelstein BL. Disparities in oral health and access to care: findings of national surveys. Ambul Pediatr. 2002 Mar-Apr;2(2 Suppl):141-7. doi: 10.1367/1539-4409(2002)0022.0.co;2.

  PMID: 11950385 BACKGROUND

• 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. doi: 10.1542/peds.2006-1958.

  PMID: 17332174 BACKGROUND

• 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. doi: 10.1542/peds.2004-1269.

  PMID: 15520094 BACKGROUND

• 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. doi: 10.1542/peds.106.6.e84.

  PMID: 11099627 BACKGROUND

• 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. doi: 10.2105/ajph.92.1.53.

  PMID: 11772761 BACKGROUND

• 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. doi: 10.2105/AJPH.2004.054858. Epub 2005 Jul 7.

  PMID: 16006416 BACKGROUND

• 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. doi: 10.2105/AJPH.2004.045286.

  PMID: 16043666 BACKGROUND

• 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.

  PMID: 16435644 BACKGROUND

• 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.

  PMID: 16541878 BACKGROUND

• 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. doi: 10.1016/s0749-3797(02)00449-x.

  PMID: 12091093 BACKGROUND

Study Officials

• Matthew F. Daley, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Patricia Braun, MD

  University of Colorado, Denver

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 5, 2013

Record last verified: 2009-01

Locations

US (5)