Early Childhood Caries Prevention at a Pediatric Clinic

Dental Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497029
• Other study ID #: Minah-1
• Status: Completed
• Phase: N/A
• Start date: June 2004
• Est. completion date: August 2006

Study information

• Verified date: July 2007
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 27 Months

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• fluoride varnish

Behavioral:
• patient education

Locations

Country	Name	City	State
United States	University of Maryland Medical Center: Pediatric Ambulatory Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. doi: 10.1111/j.1600-0722.1983.tb00845.x. — View Citation

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. doi: 10.14219/jada.archive.2006.0356. — View Citation

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. doi: 10.1016/j.amepre.2003.12.001. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1046/j.1365-263x.2001.00255.x. — View Citation

Grindefjord M, Dahllof G, Nilsson B, Modeer T. Prediction of dental caries development in 1-year-old children. Caries Res. 1995;29(5):343-8. doi: 10.1159/000262090. — View Citation

Kohler B, Andreen 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. doi: 10.1111/j.1399-302x.1988.tb00598.x. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1177/154405910608500211. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dmfs scores		12 months
Secondary	caries-preventive behaviors by care-givers		12 months