Early Childhood Caries Prevention at a Pediatric Clinic
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|ClinicalTrials.gov Identifier: NCT00497029|
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: fluoride varnish Behavioral: patient education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||August 2006|
- dmfs scores [ Time Frame: 12 months ]
- caries-preventive behaviors by care-givers [ Time Frame: 12 months ]
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
|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|