Two-year clinical evaluation of a pit and fissure sealant. Part II. Caries initiation and progression.

For the study, 479 paired permanent teeth and 20 paired deciduous teeth were coated under controlled clinical conditions with Nuva-Seal. A red dye was added to assist in placement and subsequent evaluation over a two-year period. Eighty-four children (ages 10 to 14) participated in the study. Caries was evaluated 3, 6, 12, and 24 months later with the same rating scale used at the baseline examination (0, caries free, to 4, severe caries), except when the sealant was found completely present and intact; then caries evaluation was limited to visual inspection through the sealant. The caries rate for control teeth was 6.9% at 3 months, 16.1% at 6 months, 26.4% at 12 months, and 37.6% at 24 months. Corresponding percent effectiveness figures for the sealant were 63.6%, 66.6%, 61.7%, and 54.6%, respectively. At 24 months, effectiveness rates for all types of teeth were at least 52% with the exception of the maxillary second molars (only 27% sealant effectiveness). Overall, caries protection as reflected by percent effectiveness was higher for mandibular teeth and premolars than for maxillary teeth and molars. There was significant effect on the incidence of dental caries when the sealant remained completely intact. Percentage effectiveness rates in this case were 90.7% at 12 months and 90.9% at 24 months. There was little gain or loss in caries protection when the sealant was partially or completely missing. Twenty-four percent of the children had a positive net gain or treatment effect at three months. This increased to 52% at 6 months, 62% at 12 months, and 70% at 24 months. With the use of half-mouth caries rates, the corresponding figures for positive treatment effects were slightly higher (30%, 64%, 70%, and 80% respectively).