Durability of a low shrinkage TEGDMA/HEMA-free resin composite system in Class II restorations. A 6-year follow up

The objective of this randomized controlled prospective trial was to evaluate the durability of a low shrinkage and TEGDMA/HEMA-free resin composite system in posterior restorations in a 6-year follow up.

139 Class II restorations were placed in 67 patients with a mean age of 53 years (range 29-82). Each participant received at random two, as similar as possible, Class II restorations. In the first cavity of each pair the TEGDMA/HEMA-free resin composite system was placed with its 3-step etch-and-rinse adhesive (cmf-els). In the second cavity a 1-step HEMA-free self-etch adhesive was used (AdheSe One F). The restorations were evaluated using slightly modified USPHS criteria at baseline and then yearly during 6 years. Caries risk and parafunctional habits of the participants were estimated.

Three molar teeth showed mild post-operative sensitivity during 3 weeks for temperature changes and occlusal forces. After 6 years, 134 Class II restorations were evaluated. Twenty-one restorations, 8 cmf-els (11.4%) and 13 ASE-els (20%) failed during the 6 years (p<0.0001). The annual failure rates were 1.9% and 3.3%, respectively. The main reasons for failure were fracture followed by recurrent caries. Most fractures and all caries lesions were found in high risk participants.

The Class II resin composite restorations performed with the new TEGDMA/HEMA-free low shrinkage resin composite system showed good durability over six years.