An interventional study of fluoride varnish and patient education in Dental Caries, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 6 Months to 27 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 219 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
dmfs scores
Time frame: 12 months
caries-preventive behaviors by care-givers
Time frame: 12 months
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore