Early Childhood Caries Prevention at a Pediatric Clinic
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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 |
- dmfs scores [ Time Frame: 12 months ]
- caries-preventive behaviors by care-givers [ Time Frame: 12 months ]
| Enrollment: | 219 |
| Study Start Date: | June 2004 |
| Study Completion Date: | August 2006 |
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 |
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| United States, Maryland | |
| University of Maryland Medical Center: Pediatric Ambulatory Center | |
| Baltimore, Maryland, United States, 21201 | |
| 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 May 16, 2013