Methods: 37 patients (40.6 ± 13.1a) received at least one pair of class II restorations (n=102 in total) in a randomized way. Two comparable cavities were filled with either Filtek Silorane/ Silorane System Adhesive (3 M ESPE) or Grandio/ Futurabond NR (VOCO) according to manufacturers' instructions. After 12 months, restorations (n=97, 95% recall) and the clinical situation were evaluated (examiner-blinded) according to the new evaluation criteria of Hickel et al. (Clin Oral Investig 2007;11:5-33) establishing a new score-range of 1-5 (1-3 clinically acceptable, 4-5 clinically not acceptable). In addition enamel cracks were recorded. Statistical analysis was carried out with the Wilcoxon-test (Bonferroni adjustment).
Results: Scores (1/2/3/4/5) [%] were: Surface luster: Silorane (35/63/2/0/0), Grandio (16/80/4/0/0), Surface staining: Silorane (81/17/0/2/0), Grandio (86/14/0/0/0), Color stability/translucency: Silorane (29/54/17/0/0), Grandio (20/60/20/0/0), Anatomical form: Silorane (65/29/6/0/0), Grandio (57/43/0/0/0), Fractures and retention: Silorane (96/0/2/2/0), Grandio (98/2/0/0/0), Marginal adaptation: Silorane (50/48/2/0/0), Grandio (61/37/2/0/0), Wear: Silorane (52/44/4/0/0), Grandio (37/63/0/0/0), Contact point: Silorane (81/2/17/0/0), Grandio (86/2/12/0/0), Patients' view: Silorane (90/4/4/2/0), Grandio (94/4/2/0/0), hypersensitivity/tooth vitality: Silorane (92/2/6/0/0), Grandio (86/6/8/0/0), Tooth integrity: Silorane (48/44/8/0/0), Grandio (47/49/4/0/0), Periodontal response: Silorane (60/23/17/0/0), Grandio (49/24/27/0/0), Oral health: Silorane (79/17/4/0/0), Grandio (78/18/4/0/0). No recurrent caries was recorded in both groups. The enamel crack index was added up to 0,06 for the Silorane group and 0,07 for the Grandio group.
Conclusion: Both restoratives did not show any statistical significant differences in their clinical performance so far. Therefore, after one year, Filtek Silorane was found to be efficacious in clinical use.
This study was supported by 3M ESPE, Seefeld, Germany