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Clinical Trials/NCT00497029
NCT00497029CompletedNot Applicable

Early Childhood Caries Prevention at a Pediatric Clinic

University of Maryland, Baltimore1 site in 1 country219 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
219
Locations
1
Primary Endpoint
dmfs scores

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Months to 27 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

dmfs scores

Time Frame: 12 months

Secondary Outcomes

  • caries-preventive behaviors by care-givers(12 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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