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Early Childhood Caries Prevention at a Pediatric Clinic

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497029
Enrollment
219
Registered
2007-07-06
Start date
2004-06-30
Completion date
2006-08-31
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, early childhood caries, caries prevention, infants

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.

Interventions

DRUGfluoride varnish
BEHAVIORALpatient education

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 27 Months
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

Design outcomes

Primary

MeasureTime frame
dmfs scores12 months

Secondary

MeasureTime frame
caries-preventive behaviors by care-givers12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026