RESUMEN
AIM: Evaluating the clinical survival and quality parameters of class-II restorations using 3M™ FiltekTM Bulk Fill Posterior Restorative compared to 3M™ FiltekTM Supreme XTE Universal Restorative over a period of five years. MATERIALS AND METHODS: A longitudinal, randomized, prospective split-mouth study with 60 patients (29 female, 31 male; mean age 44 y; range 20-77 y) and a total of 120 load-bearing class II restorations (TEST: n=60 Filtek Bulk Fill Posterior Restorative; CONTROL: n=60 Filtek Supreme XTE Universal Restorative) was conducted. Clinical evaluation was performed by blinded evaluators according to FDI criteria. Kaplan-Meier method was used for survival analysis and an intergroup comparison (Mann-Whitney-U-Test) was carried out. A basic significance level of 0.05 was corrected by the Bonferroni method to account for multiple testing (significance after correction: p<0.00067). RESULTS: The mean overall survival of restorations was 92% after 56.98±1.51 months in the TEST group (95 CI= 54.02;59.94) and 92% after 57.25±1.46 months (95 CI= 54.39; 60.12) in the CONTROL group (log-rank p=0.995). In total, four failures occurred in both TEST and CONTROL group during the observation period (mean annual failure rate: 1.6%). The most common reasons for failure were chipping-fractures, debonding, cracked-tooth-syndrome and recurrent decay. With regard to the FDI criteria, no significant differences between TEST and CONTROL material occurred for any of the evaluated variables. In the TEST group two restorations had to be repaired and two had to be replaced, in the CONTROL group four restorations had to be replaced. CONCLUSION: Both materials showed acceptable clinical performance and survival during the 5-year observation period. CLINICAL SIGNIFICANCE: The use of a nanofilled bulk-fill composite proved to be an aesthetically, functionally and biologically satisfactory alternative in posterior dentition.
Asunto(s)
Caries Dental , Restauración Dental Permanente , Humanos , Masculino , Femenino , Adulto , Restauración Dental Permanente/métodos , Estudios Prospectivos , Resinas Compuestas , Caries Dental/terapia , Boca , CaraRESUMEN
OBJECTIVES: The aim of this randomized controlled clinical trial was to evaluate the clinical survival and quality parameters of class-II restorations using a bulk-fill composite resin compared to a conventional nanohybrid composite resin in a split-mouth design. METHODS: One hundred and twenty direct restorations were placed in stress bearing class II cavities (n = 60 test group: Filtek™ Bulk Fill Posterior and n = 60 control group: Filtek™ Supreme XTE) in adult permanent teeth. Survival and clinical quality were evaluated at baseline and after 3 years using modified World Dental Federation (FDI) criteria. Participants and clinical evaluators were blinded relating to the group assignment of the restorations. RESULTS: Seventeen restorations (14.2%) were lost to follow-up, leading to 51 restorations available for survival analysis in the test group and 52 restorations in the control group. Seven restorations showed unfavorable events and were classified as failure. Four bulk-fill restorations failed due to tooth infracture (n = 1), chipping fractures (n = 2) and recurrent decay (n = 1), whereas three conventional nanohybrid composite restorations failed due to adhesive failure (n = 1), tooth infracture (n = 1) and chipping as well as recurrent decay (n = 1). The mean annual failure rate was 2.4% and 1.8%, respectively. The difference between test and control group was not significant (p = 0.7). Data on the detailed assessment of FDI criteria were available for n = 48 and n = 49 restorations, respectively. No significant differences between the two groups could be found regarding the assessment of esthetic, functional and biological properties. SIGNIFICANCE: Both materials showed similar clinical performance and survival. The use of bulk-fill composite proved to be an esthetically, functionally and biologically satisfactory alternative in the posterior dentition during the 3-year follow-up.