NCT00497029

Brief Summary

This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
Last Updated

May 8, 2023

Status Verified

July 1, 2007

First QC Date

July 5, 2007

Last Update Submit

May 4, 2023

Conditions

Dental Caries

Keywords

dental cariesearly childhood cariescaries preventioninfants

Outcome Measures

Primary Outcomes (1)

  • dmfs scores

    12 months

Secondary Outcomes (1)

  • caries-preventive behaviors by care-givers

    12 months

Interventions

fluoride varnishDRUG
patient educationBEHAVIORAL

Eligibility Criteria

Age6 Months - 27 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children in good health who were dentate and 6-27 months
  • a signed informed consent

You may not qualify if:

  • antibiotic usage within the previous 14 days
  • oral topical fluoride administration within the previous 7 days
  • previous routine professional dental care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center: Pediatric Ambulatory Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (12)

  • Newacheck PW, Hughes DC, Hung YY, Wong S, Stoddard JJ. The unmet health needs of America's children. Pediatrics. 2000 Apr;105(4 Pt 2):989-97.

    PMID: 10742361BACKGROUND

  • Gomez SS, Weber AA. Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring. Int J Paediatr Dent. 2001 Mar;11(2):117-22. doi: 10.1046/j.1365-263x.2001.00255.x.

    PMID: 11310134BACKGROUND

  • Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6. doi: 10.1177/154405910608500211.

    PMID: 16434737BACKGROUND

  • Recommendations for using fluoride to prevent and control dental caries in the United States. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2001 Aug 17;50(RR-14):1-42.

    PMID: 11521913BACKGROUND

  • American Dental Association Council on Scientific Affairs. Professionally applied topical fluoride: evidence-based clinical recommendations. J Am Dent Assoc. 2006 Aug;137(8):1151-9. doi: 10.14219/jada.archive.2006.0356.

    PMID: 16873333BACKGROUND

  • Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.

    PMID: 12959161BACKGROUND

  • Bader JD, Rozier RG, Lohr KN, Frame PS. Physicians' roles in preventing dental caries in preschool children: a summary of the evidence for the U.S. Preventive Services Task Force. Am J Prev Med. 2004 May;26(4):315-25. doi: 10.1016/j.amepre.2003.12.001.

    PMID: 15110059BACKGROUND

  • Douglass JM, Douglass AB, Silk HJ. Infant oral health education for pediatric and family practice residents. Pediatr Dent. 2005 Jul-Aug;27(4):284-91.

    PMID: 16317967BACKGROUND

  • Grindefjord M, Dahllof G, Nilsson B, Modeer T. Prediction of dental caries development in 1-year-old children. Caries Res. 1995;29(5):343-8. doi: 10.1159/000262090.

    PMID: 8521434BACKGROUND

  • Barsamian-Wunsch P, Park JH, Watson MR, Tinanoff N, Minah GE. Microbiological screening for cariogenic bacteria in children 9 to 36 months of age. Pediatr Dent. 2004 May-Jun;26(3):231-9.

    PMID: 15185804BACKGROUND

  • Alaluusua S, Renkonen OV. Streptococcus mutans establishment and dental caries experience in children from 2 to 4 years old. Scand J Dent Res. 1983 Dec;91(6):453-7. doi: 10.1111/j.1600-0722.1983.tb00845.x.

    PMID: 6581521BACKGROUND

  • Kohler B, Andreen I, Jonsson B. The earlier the colonization by mutans streptococci, the higher the caries prevalence at 4 years of age. Oral Microbiol Immunol. 1988 Mar;3(1):14-7. doi: 10.1111/j.1399-302x.1988.tb00598.x. No abstract available.

    PMID: 3268743BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Glenn E Minah, DDS, PhD

    Department of Biomedical Sciences, University of Maryland Dental School

    PRINCIPAL INVESTIGATOR

  • Lindsey K Grossman, MD

    Department of Pediatrics, University of Maryland School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

June 1, 2004

Study Completion

August 1, 2006

Last Updated

May 8, 2023

Record last verified: 2007-07

Locations

US(1)