Early Childhood Caries Prevention at a Pediatric Clinic

This study has been completed.
Sponsor:
Information provided by:
University of Maryland Baltimore Dental School
ClinicalTrials.gov Identifier:
NCT00497029
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Dental Caries
Drug: fluoride varnish
Behavioral: patient education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Maryland Baltimore Dental School:

Primary Outcome Measures:
  • dmfs scores [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • caries-preventive behaviors by care-givers [ Time Frame: 12 months ]

Enrollment: 219
Study Start Date: June 2004
Study Completion Date: August 2006
Detailed Description:

A demonstration caries prevention trial lasting 26 months was conducted with a total of 219 children aged 6 to 27 months of age. The “prevention” group consisting of children 6-15 months of age at their initial visit were compared at the end of the trial with a “comparison” group at their initial visit. The comparison group was 12 months older than the enrollment age of the prevention group (18-27 months) and had not received previous routine professional dental care. Interventions were dental examination and periodic recalls, caries-risk assessments, monitoring of oral mutans streptococci (MS) levels, application of 5.0% sodium fluoride varnish to teeth, dental health counseling to care-givers, referral for dental treatment if indicated and periodic recalls.

Outcome measures were: 1) number of decayed, missing, filled primary tooth surfaces, 2) number of pre-carious lesions, 3) counts of oral MS and 3) care-giver responses to a questionnaire about the child’s diet and home care.

Prevention group children at the last recall experienced fewer mean carious dental surfaces (0.1 vs. 1.29, p<0.014) and over 8-fold less MS (p<0.013) than comparison group subjects at the initial visit. The number of precarious lesions, however, were not significantly different. In the absence of carious or precarious lesions, oral levels of MS was a reliable indicator of caries risk status, particularly for low risk subjects (sensitivity, 0.64; specificity, 0.98). Caregiver reports of dietary practices and presence or absence of visible dental plaque also served as caries-risk determinants.

  Eligibility

Ages Eligible for Study:   6 Months to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • antibiotic usage within the previous 14 days
  • oral topical fluoride administration within the previous 7 days
  • previous routine professional dental care
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497029

Locations
United States, Maryland
University of Maryland Medical Center: Pediatric Ambulatory Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland Baltimore Dental School
Investigators
Principal Investigator: Glenn E Minah, DDS, PhD Department of Biomedical Sciences, University of Maryland Dental School
Study Director: Lindsey K Grossman, MD Department of Pediatrics, University of Maryland School of Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00497029     History of Changes
Other Study ID Numbers: Minah-1
Study First Received: July 5, 2007
Last Updated: July 5, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland Baltimore Dental School:
dental caries
early childhood caries
caries prevention
infants

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014