Five-year evaluation of a low-shrinkage Silorane resin composite material: a randomized clinical trial

The aim of the present study was to investigate the clinical performance of a low-shrinkage silorane-based composite material (Filtek™ Silorane, 3 M-Espe) by comparing it with a methacrylate-based composite material (Ceram•X™, Dentsply DeTrey).

A number of 72 patients (158 restorations) participated in the study. After 5 years, a total of 107 restorations (52 Filtek™ Silorane, 55 Ceram•X™) in 48 patients were evaluated. Only class II restorations were included. All the restorations were placed by the same dentist, and the restorations were scored by one experienced dentist/evaluator. Materials were applied following the manufacturer's instructions. The primary outcome was marginal adaptation. Secondary outcomes were: marginal discoloration, approximal contact, anatomic form, fracture, secondary caries, and hypersensitivity.

After 5 years, no statistically significant differences between the two materials were found in marginal adaptation either occlusally (p = 0.96) or approximally (p = 0.62). No statistically significant differences were found between the two materials in terms of approximal contact, anatomic form, fractures, or discoloration. Secondary caries was found in two teeth (Filtek™ Silorane). One tooth showed hypersensitivity (Ceram•X™).

Restorations of both materials were clinically acceptable after 5 years. This study did not find any advantage of the silorane-based composite over the methacrylate-based composite, which indicates that the low-shrinkage of Filtek™ Silorane may not be a determinant factor for clinical success in class II cavities.

This paper is the first to evaluate the 5-year clinical performance of a low-shrinkage composite material.