Clinical trial NCT00497029: Early Childhood Caries Prevention at a Pediatric Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
early childhood caries
caries prevention
infants
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 219
Sex: ALL
Minimum age (years): 6
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: dmfs scores
timeFrame: 12 months
Secondary outcomes:
measure: caries-preventive behaviors by care-givers
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center: Pediatric Ambulatory Center
state: Maryland
Study officials:
affiliation: Department of Biomedical Sciences, University of Maryland Dental School
name: Glenn E Minah, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, University of Maryland School of Medicine
name: Lindsey K Grossman, MD
role: STUDY_DIRECTOR
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