10-Year Clinical Performance of Packable Posterior Composite

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Introduction: Early laboratory testing suggested poor wear resistance for some packable composites versus traditional hybrids.    Objective:  Evaluate 10y clinical performance of a promising packable composite versus ADA-4y guidelines (1989) for acceptance of “unrestricted” amalgam-replacement materials and linearly-extrapolated 10y-ADA guidelines.   Methods:  60 packable composite restorations (20% Class-I; 80% Class-II) originally were placed in 30 patients (62% women; 65% 1st-molars and 35% 2nd-molars; mean age = 42y) as large preparations (FL width ³⅓ intercuspal distance; no bevels) with normal techniques (local anesthesia; rubber dam).  Enamel and dentin were total-etched (15s of 34%-H3PO4; 10s rinse), bonded (P&B-2.1 [Dentsply]), and restored (SureFil [Dentsply], 1997).  Wear was rated (Leinfelder method; 6m baseline-subtracted) and analyzed (ANOVA, a=0.05, see superscripts).  Cumulative failures (%F) for restorations and individual modified-USPHS categories for color match (cm), marginal discoloration (md), secondary caries (sc), marginal integrity (mi), interproximal contact (ic), and post-op sensitivity (ps) were tallied and compared to linearly-extrapolated (=2.5X) 10y-ADA guidelines.    Results:  10y results passed both 4y and 10y guidelines.  Wear increased from 5y-to-10y (p=0.0001), showed strong linear regression with time (r2=0.96, see figure), had not yet leveled off, but was low (~14 µm/y).                        Cumulative Failures (%F)    Pts  Rests  Wear (µm±sd)    Restorations    cm  md  sc  mi  ic  ps   ADA-4y  20  ---       ≤100  ≤10%  ≤10%  ≤15%  ≤5%  ≤10%  ≤10%  ---  ADA-10y  ---  ---       ≤250  ≤25%  ≤25%  ≤38%  ≤12%  ≤25%  ≤25%  ---   UNC-0y  30  60       -----  0% (n=0/60)  0%  0%  0%  0%  0%  0%   UNC-2y  28  53      5±18a (n=45)  4% (n=2/53)  0%  0%  0%  0%  0%  4%   UNC-4y  26  44    52±30b (n=44)  7% (n=1/44)  0%  0%  2%  0%  0%  4%   UNC-5y  21  37    46±41b (n=37)  9% (n=1/40)  0%  3%  5%  3%  3%  5%   UNC-10y  11  17  142±71c (n=17)  9% (n=0/17)  0%  3%  5%  6%  6%  5% Conclusion:  This packable composite demonstrated excellent clinical performance and passed all guidelines.    Acknowledgment: Supported by Dentsply-Caulk.