title: Direct contra naïve-indirect comparison of clinical failure rates between high-viscosity GIC and conventional amalgam restorations: an empirical study.
abstract: BACKGROUND
  Naïve-indirect comparisons are comparisons between competing clinical interventions' evidence from separate (uncontrolled) trials. Direct comparisons are comparisons within randomised control trials (RCTs). The objective of this empirical study is to test the null-hypothesis that trends and performance differences inferred from naïve-indirect comparisons and from direct comparisons/RCTs regarding the failure rates of amalgam and direct high-viscosity glass-ionomer cement (HVGIC) restorations in permanent posterior teeth have similar direction and magnitude.
  
  
  METHODS
  A total of 896 citations were identified through systematic literature search. From these, ten and two uncontrolled clinical longitudinal studies for HVGIC and amalgam, respectively, were included for naïve-indirect comparison and could be matched with three out twenty RCTs. Summary effects sizes were computed as Odds ratios (OR; 95% Confidence intervals) and compared with those from RCTs. Trend directions were inferred from 95% Confidence interval overlaps and direction of point estimates; magnitudes of performance differences were inferred from the median point estimates (OR) with 25% and 75% percentile range, for both types of comparison. Mann-Whitney U test was applied to test for statistically significant differences between point estimates of both comparison types.
  
  
  RESULTS
  Trends and performance differences inferred from naïve-indirect comparison based on evidence from uncontrolled clinical longitudinal studies and from direct comparisons based on RCT evidence are not the same. The distributions of the point estimates differed significantly for both comparison types (Mann-Whitney U  =  25, n(indirect)  =  26; n(direct)  =  8; p  =  0.0013, two-tailed).
  
  
  CONCLUSIONS
  The null-hypothesis was rejected. Trends and performance differences inferred from either comparison between HVGIC and amalgam restorations failure rates in permanent posterior teeth are not the same. It is recommended that clinical practice guidance regarding HVGICs should rest on direct comparisons via RCTs and not on naïve-indirect comparisons based on uncontrolled longitudinal studies in order to avoid inflation of effect estimates.
authors.affiliation: Systematic Review initiative for Evidence-based Minimum Intervention in Dentistry/Department of Community Dentistry, Faculty of Health Sciences, University of the Witwatersrand - Johannesburg, South Africa.
authors.forename: Steffen
authors.initials: S
authors.lastname: Mickenautsch
authors.forename: Veerasamy
authors.initials: V
authors.lastname: Yengopal
mesh_terms: D035843:Biomedical Research / Q000379:methods; D003723:Dental Amalgam / Q000627:therapeutic use*; D003729:Dental Care / Q000379:methods; D003731:Dental Caries / Q000628:therapy; D019232:Dental Restoration Failure; D003793:Dental Restoration, Permanent / Q000379:methods*; D005899:Glass Ionomer Cements / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D012107:Research Design; D014783:Viscosity
chemical_list: D005899:Glass Ionomer Cements; D003723:Dental Amalgam