A Phase 3 interventional study of Chlorhexidine gluconate and Fluoride Varnish in Dental Caries, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 33 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Prevention
The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
The primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing Early Childhood Caries. A four-year randomized clinical trial will be conducted specifically to: 1) Assess demographic and behavioral factors as predictors of ECC and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) Compare the efficacy for the prevention of ECC in two groups - the minimal intervention group (Group 1) receiving counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) Assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process.
The long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (U.S. - Mexico Border near San Diego Bay Area) at high risk for dental disease.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 361 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
"Inclusion Criteria"
"Exclusion Criteria"
Oral Health Counseling Only
Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child
Drug: Chlorhexidine gluconate · Device: Fluoride Varnish
0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months
Also known as: Peridex® OMNII Oral Pharmaceuticals
0.25ml FV every 6 months from age 12 to 30 months
Also known as: CavityShield® OMNII Oral Pharmaceuticals
Caries Incidence and Caries Index
Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.
Time frame: 4 year
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco