Compomer restorations release fluoride to help prevent future caries. We tested the hypothesis that compomer is associated with fewer future caries compared with amalgam. The five-year New England Children's Amalgam Trial recruited 534 children aged 6-10 yrs with >or= 2 carious posterior teeth. Children were randomized to receive compomer or amalgam restorations in primary posterior teeth, placed with a fluoride-releasing bonding agent. The association between restorative material and future caries was assessed by survival analysis. Average follow-up of restorations (N = 1085 compomer, 954 amalgams) was 2.8 + 1.4 yrs in 441 children. No significant difference between materials was found in the rate of new caries on different surfaces of the same tooth. Incident caries on other teeth appeared slightly more quickly after placement of compomer restorations (p = 0.007), but the difference was negligible after 5 yrs. Under the conditions of this trial, we found no preventive benefit to fluoride-releasing compomer compared with amalgam.
Trial registration: ClinicalTrials.gov NCT00065988.