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Early Childhood Caries Prevention at a Pediatric Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497029
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Information provided by:
University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: fluoride varnish Behavioral: patient education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Fluoride

Primary Outcome Measures :
  1. dmfs scores [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. caries-preventive behaviors by care-givers [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 27 Months   (Child)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497029

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United States, Maryland
University of Maryland Medical Center: Pediatric Ambulatory Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
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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

Layout table for additonal information Identifier: NCT00497029    
Other Study ID Numbers: Minah-1
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007
Keywords provided by University of Maryland, Baltimore:
dental caries
early childhood caries
caries prevention
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs