Early Childhood Caries Prevention at a Pediatric Clinic
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluoride varnish
patient education
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring dental caries, early childhood caries, caries prevention, infants
Eligibility 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
Sites / Locations
- University of Maryland Medical Center: Pediatric Ambulatory Center
Outcomes
Primary Outcome Measures
dmfs scores
Secondary Outcome Measures
caries-preventive behaviors by care-givers
Full Information
NCT ID
NCT00497029
First Posted
July 5, 2007
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT00497029
Brief Title
Early Childhood Caries Prevention at a Pediatric Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, early childhood caries, caries prevention, infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluoride varnish
Intervention Type
Behavioral
Intervention Name(s)
patient education
Primary Outcome Measure Information:
Title
dmfs scores
Time Frame
12 months
Secondary Outcome Measure Information:
Title
caries-preventive behaviors by care-givers
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
27 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn E Minah, DDS, PhD
Organizational Affiliation
Department of Biomedical Sciences, University of Maryland Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lindsey K Grossman, MD
Organizational Affiliation
Department of Pediatrics, University of Maryland School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of Maryland Medical Center: Pediatric Ambulatory Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10742361
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.
Results Reference
background
PubMed Identifier
11310134
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.
Results Reference
background
PubMed Identifier
16434737
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.
Results Reference
background
PubMed Identifier
11521913
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.
Results Reference
background
PubMed Identifier
16873333
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.
Results Reference
background
PubMed Identifier
12959161
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.
Results Reference
background
PubMed Identifier
15110059
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.
Results Reference
background
PubMed Identifier
16317967
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.
Results Reference
background
PubMed Identifier
8521434
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.
Results Reference
background
PubMed Identifier
15185804
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.
Results Reference
background
PubMed Identifier
6581521
Citation
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.
Results Reference
background
PubMed Identifier
3268743
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.
Results Reference
background
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Early Childhood Caries Prevention at a Pediatric Clinic
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