Four-year clinical evaluation of a self-etching primer and resin-based restorative material.
PURPOSE: To evaluate the performance of a universal resin-based restorative material (Beautifil) in combination with a self-etching primer (Fluorobond) for posterior restorations. METHODS: 61 restorations, 26 Class I and 35 Class II, were placed by two clinicians in 31 patients under rubber dam isolation. Two other calibrated clinicians evaluated the restorations using USPHS/Ryge criteria observing the following characteristics: color match, marginal adaptation, anatomy, roughness, marginal staining, interfacial staining, contact, secondary caries, and luster. Chi-Square and Fisher's Exact Test were used for statistical analysis (alpha=0.05). RESULTS: All the restorations were assessed at baseline and alpha scores predominated for all criteria. All restorations were examined at the 1-year recall examination. 58 restorations were examined at the 2-year recall (23 Class I and 35 Class II), 47 (16 Class I and 31 Class II) at the 3-year recall. The present 4-year report covers 39 restorations (12 Class I and 27 Class II). Marginal adaptation, staining, anatomy, and color matching constitute the majority of the recorded changes. Chi-Square and Fisher's Exact Test of the frequency of clinical rating of each characteristic showed that there were no statistically significant differences at each recall with respect to the baseline observations (P> 0.05), except for occlusal marginal stain. Statistical significance was detected for the occlusal marginal stain at 1-year (P= 0.06), 2-year (P= 0.01) and 4-year (P= 0.002) when compared to baseline data.