Treatment of intraosseous defects with bioabsorbable barriers alone or in combination with decalcified freeze-dried bone allograft: a randomized clinical trial.

ABSTRACT

BACKGROUND: This study clinically compares the outcomes obtained from the use of a bioabsorbable barrier device in combination with demineralized freeze-dried bone allograft (DFDBA) to the results obtained from the barrier device used alone in the treatment of human intraosseous defects. METHODS: The study consisted of 30 patients with one intraosseous periodontal defect each. The trial included defects with loss of attachment of > or = 6 mm, with a radiographically detectable defect of at least 4 mm and with at least 2 remaining osseous walls. After the hygienic phase, at baseline, probing depth (PD), clinical attachment level (CAL), and recession (REC) were measured. During open flap debridement, the defects were randomly assigned to receive either a polylactic acid (PLA) barrier in combination with DFDBA (test) or a PLA barrier alone (control). Additionally, baseline osseous intrasurgical measurements of the periodontal defect were obtained to evaluate the amount of bone regeneration. PD, CAL, and REC were remeasured at 6 and 12 months postsurgery and osseous measurements repeated at 12 months during a re-entry procedure. RESULTS: Two-sample t-test comparisons of mean PD, CAL, and REC measurements (mm) between test (PLA+DFDBA) and control (PLA alone) groups at baseline, PLA+DFDBA PD = 7.3, CAL = 8.1, REC = -0.7; PLA-alone PD = 7.9, CAL = 8.4, REC = -0.5, were not statistically different (P>0.05). The following mean changes (delta) at 6 months for the test and the control groups were decreased PD = 3.6 and 4.0 mm; gain CAL = 2.7 and 3.1 mm; and increased REC = -0.8 and -0.8 mm, respectively. At 12 months the changes for the test and control groups were decreased PD = 3.3 and 4.1 mm; gain CAL = 2.3 and 3.2 mm; and increased REC = -0.8 and -1.0 mm, respectively. Two-sample t-test comparisons between PD, CAL, and REC changes yielded no significant differences between treatments (P > 0.05), except for the change in CAL at 12 months in favor of the control group, P = 0.008. Comparisons of osseous measurements resulted in no significant differences between groups at baseline and at 12 months (P > 0.05). The intrabony defect filled on the average 3.72 mm for the test and 4.85 mm for the control group. The experimental defects showed a 4.73 mm defect depth reduction, while the control defects reduced 5.35 mm. Re-entry measurements of osseous crest resorption were 1.1 mm for the test and 0.61 mm for the control. CONCLUSIONS: In the intraosseous defects treated in this study, the addition of DFDBA to the GTR procedure did not significantly enhance the clinical results obtained with the GTR procedure alone.