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Early Childhood Caries Prevention at a Pediatric Clinic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497029
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
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.
Information provided by:
University of Maryland Baltimore Dental School
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Maryland Baltimore Dental School:

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

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

Enrollment: 219
Study Start Date: June 2004
Study Completion Date: August 2006
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

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00497029


Locations
United States, Maryland
University of Maryland Medical Center: Pediatric Ambulatory Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland Baltimore Dental School
Investigators
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:
Newacheck PW, Hughes DC, Hung YY, Wong S, Stoddard JJ. The unmet health needs of America's children. Pediatrics. 2000 Apr;105(4 Pt 2):989-97.
Gomez SS, Weber AA. Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring. Int J Paediatr Dent. 2001 Mar;11(2):117-22.
Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6.
Recommendations for using fluoride to prevent and control dental caries in the United States. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2001 Aug 17;50(RR-14):1-42.
American Dental Association Council on Scientific Affairs. Professionally applied topical fluoride: evidence-based clinical recommendations. J Am Dent Assoc. 2006 Aug;137(8):1151-9.
Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003 Aug;67(8):876-85.
Bader JD, Rozier RG, Lohr KN, Frame PS. Physicians' roles in preventing dental caries in preschool children: a summary of the evidence for the U.S. Preventive Services Task Force. Am J Prev Med. 2004 May;26(4):315-25.
Douglass JM, Douglass AB, Silk HJ. Infant oral health education for pediatric and family practice residents. Pediatr Dent. 2005 Jul-Aug;27(4):284-91.
Grindefjord M, Dahllöf G, Nilsson B, Modéer T. Prediction of dental caries development in 1-year-old children. Caries Res. 1995;29(5):343-8.
Barsamian-Wunsch P, Park JH, Watson MR, Tinanoff N, Minah GE. Microbiological screening for cariogenic bacteria in children 9 to 36 months of age. Pediatr Dent. 2004 May-Jun;26(3):231-9.
Alaluusua S, Renkonen OV. Streptococcus mutans establishment and dental caries experience in children from 2 to 4 years old. Scand J Dent Res. 1983 Dec;91(6):453-7.
Köhler B, Andréen I, Jonsson B. The earlier the colonization by mutans streptococci, the higher the caries prevalence at 4 years of age. Oral Microbiol Immunol. 1988 Mar;3(1):14-7.

ClinicalTrials.gov Identifier: NCT00497029     History of Changes
Other Study ID Numbers: Minah-1
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
Last Verified: July 2007

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
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs


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