Jan W V van Dijken1, Ulla Pallesen2. 1. Department of Odontology, Faculty of Medicine, Umeå University, Umeå, Sweden. Electronic address: Jan.van.Dijken@odont.umu.se. 2. Institute of Odontology, Faculty of Health Science, University of Copenhagen, Denmark.
Abstract
OBJECTIVE: 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. METHODS: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. RESULTS: 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. SIGNIFICANCE: The Class II resin composite restorations performed with the new TEGDMA/HEMA-free low shrinkage resin composite system showed good durability over six years.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. SIGNIFICANCE: The Class II resin composite restorations performed with the new TEGDMA/HEMA-free low shrinkage resin composite system showed good durability over six years.
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