GC EUROPE Unifil Bond - Manual (Page 14)

GC UniFil Bond Technical manual version 1.10, November 2005,
14/23
7.0 Clinical investigations
One-year clinical trial of Gradia direct Class II restorations by M. FERRARI ,
A. FABIANELLI, S. GRANDINI, C. GORACCI
School of Dental Medicine, University of Siena, Italy
Objective: The objective of this study is to evaluate the safety, longevity, aesthetics
and efficacy of Gradia Class II restorations placed under clinical conditions.
Methods: 40 Class II OM or OD restorations were placed using experimental Gradia
Direct material in combination with UniFil self-etching adhesive system (GC). No
bevel or macromechanical retention was placed. The performance of Class II
restorations was assessed at baseline and at the 1 and 7 days and 1-month (for
post-op sensitivity) 6-month, 12-month recalls.Cervical margins were located
primarily in dentine. A rubber dam was applied and the restorations were placed
following an incremental technique. The patients were recalled for evaluating post-
operative sensitivity and other clinical parameters such as Marginal Integrity (MI),
marginal discoloration (MD), Color stability (CS), Surface staining (SS), Retention
(R) and Secondary caries (SC) according the Ryge criteria. Results: only one
restoration showed moderate post-op sensitivity after 1 year. Another restoration
showed slight but still acceptable discoloration (CS and SS) not requiring
replacement, with a slight discoloration at the interface (MI, MD). All restorations
showed proper retention and no secondary caries. Conclusions: The restorative
material used in this study showed acceptable clinical performance after 1 year of
clinical service. Longer clinical trials will elucidate clinical behavior of Gradia direct
resin composite in combination with UniFil bonding system.