Background: Demineralized bone matrix (DBM) and guided tissue regeneration (GTR) support substantial gains in clinical attachment level (CAL), reductions in probing depth (PD), and gains in defect fill compared to open flap debridement (OFD) in intrabony defects. Although these regenerative therapies support improvements in mean clinical parameters, it is unclear whether the procedures improve the predictability of clinical outcome. The purpose of this study was to examine the relative variability in clinical outcome measures, independent of the magnitude of gains, in regenerative studies comparing DBM or GTR to OFD therapy for the management of intrabony defects. For comparative purposes, a similar analysis was performed evaluating the consistency of clinical outcomes with other (non-DBM) bone replacement graft (BRG) materials relative to OFD alone.
Methods: Fifty-five randomized controlled clinical trials comparing regenerative therapy (seven DBM, 22 BRG, and 26 GTR) to OFD and meeting inclusion criteria provided mean change scores (pretreatment to post-treatment) and variance estimates for CAL, PD, and bone fill, allowing for calculation of a coefficient of variability (CV) for each measure within studies. The mean CV for each measure was submitted to an analysis of variance or covariance with repeated measures (P < or =0.05) to compare relative variation in treatment outcomes.
Results: DBM was associated with a significantly lower relative variability (mean +/- SE) in CAL gain (96.3 +/- 38.6 versus 137.7 +/- 30.9) and defect fill (69.1 +/- 11.2 versus 133.1 +/- 15.3) compared to OFD alone. As a group, other BRGs were found to support significant reductions in variation in CAL and defect fill. GTR therapy was associated with significantly lower CV for CAL compared to OFD (50.6 +/- 5.0 versus 68.7 +/- 8.2, respectively). Variability in defect fill was similar for GTR and OFD.
Conclusions: DBM and GTR therapy support more consistent improvements in clinical parameters; however, with the exception of defect fill following bone grafting, the reduction in variability in clinical outcomes was relatively modest compared to OFD alone. Overall, the treatment of intrabony defects is associated with a relatively high degree of variability in clinical outcome, regardless of therapeutic approach.