A two-year randomized, controlled clinical evaluation of bonded amalgam restorations.
The clinical performance of adhesively bonded dental amalgam restorations was compared with that of traditionally placed non-bonded control amalgams in a randomized prospective study.
                One-hundred thirteen Class II Dispersalloy amalgams were placed in permanent molars and premolars of 31 (21 males, 10 females) human subjects with their informed consent. By random assignment, 60 amalgam restorations were adhesively bonded using ED Primer and Panavia 21 TC (both Kuraray Co, Japan), and 53 traditional non-bonded restorations were placed. Most preparations involved replacement of defective amalgam restorations. Clinical recalls were conducted by experienced evaluators using modified USPHS criteria for occlusal and proximal anatomic form, occlusal and proximal marginal adaptation, and occlusal and proximal surface roughness.
                For the categories of anatomic form, marginal adaptation, surface quality, and temperature sensitivity, there were no significant differences between bonded and non-bonded amalgam restorations (chi-square analysis, p > 0.05). Three non-bonded restorations were lost at 4, 7, and 24 months from preparations with no deliberate retention.
                After two years' clinical service, there were no failures among the amalgam restorations adhesively bonded using ED Primer and Panavia 21 TC, but three non-bonded restorations failed due to lack of retention. For traditional preparations, adhesively bonded amalgams of the type investigated perform as well as non-bonded amalgams over two years' clinical service.
There is no evidence to either claim or refute a difference in survival between bonded and non-bonded amalgam restorations. This review only found one methodologically sound but somewhat under-reported trial. This trial did not find any significant difference in the in-service performance of moderately sized adhesively bonded amalgam restorations, in terms of their survival rate and marginal integrity, in comparison to non-bonded amalgam restorations over a 2-year period. In view of the lack of evidence on the additional benefit of adhesively bonding amalgam in comparison with non-bonded amalgam, it is important that clinicians are mindful of the additional costs that may be incurred.