A randomized clinical trial of silver diamine fluoride to arrest early childhood caries in young children
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Abstract Objective: To investigate the effectiveness of silver diamine fluoride (SDF) to arrest early childhood caries (ECC) in very young children randomized to three different application frequency groups (regimens) Methods: Children with active dentinal carious lesions (ICDAS 5 or 6) in primary teeth without any signs of pulpal involvement were randomized into three different application frequency groups; 1, 4, or 6 months apart. Children underwent treatment with 38% SDF at baseline visit and again at a second visit. Treated lesions were assessed at the second and third visits to determine arrest success. Participants were considered completely successful (CS) if all treated lesions were arrested and incompletely successful (IS) if at least one lesion was not arrested. Statistical analyses included descriptive and bivariate analyses. A p value ≤ 0.05 was significant. Results: A total of 84 children with 486 carious lesions were recruited into the study with 28 children in each group. The overall proportion of completely successful treated children at visit 2 and final visit were 40% and 68% respectively. Results of McNemar’s test showed a significant increase in complete success from 40% at second visit to 68% at visit 3 (p-value <0.001) across all groups for 84 study participants. Within each group, significant improvement in complete success at child-level was also noted with p-values of 0.041,0.023 and 0.004 for Regimen 1, 2 and 3 respectively. Participants in one month group showed a change of complete success from 36% at second visit to 71% at third visit (p-value 0.004). No significant differences were noted between the groups at second visit and final visit (p >0.05) Conclusions: Findings in this study suggested that two applications of SDF at different frequencies showed similar frequency of successfully treated cases at the child level. No difference was noted in success rates comparing three groups either at second or third visit. Results from our study were statistically insignificant when comparing the arrest rates at child level between three groups at both visits. Further analysis should investigate lesion arrest rates between the treatment groups.
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