Clinical evaluation of a biphasic calcium composite grafting material in the treatment of human periodontal intrabony defects: a 12-month randomized controlled clinical trial.

Background: The aim of this study was to compare the clinical outcome of a novel biphasic calcium composite (BCC) biomaterial versus autogenous bone spongiosa (ABS) or open flap debridement (OFD) for the treatment of intrabony periodontal defects.

Methods: Forty-five subjects with at least one intrabony defect with a probing depth (PD) >or=7 mm and a vertical radiographic bone loss >or=3 mm were enrolled in the study. Subjects were randomly assigned to treatment with BCC (n = 15), ABS (n = 15), or OFD (n = 15). Clinical parameters were recorded at baseline and 12 months after surgery and included the plaque index, gingival index, PD, clinical attachment level (CAL), and gingival recession.

Results: In all treatment groups, significant PD reductions and CAL gains occurred during the study period (P <0.0001). At 12 months, patients treated with BCC exhibited a mean PD reduction of 3.6 +/- 0.7 mm and a mean CAL gain of 3.0 +/- 0.8 mm compared to baseline. Corresponding values for patients treated with ABS were 3.4 +/- 0.8 mm and 2.9 +/- 0.9 mm, whereas OFD sites produced values of 2.8 +/- 0.8 mm and 1.6 +/- 0.7 mm. Compared to OFD, the additional CAL gain was significantly greater in patients treated with BCC (P = 0.002) and ABS (P = 0.001). The additional PD reduction was significant for the BCC group (P = 0.011) and borderline significant for the ABS group (P = 0.059). There were no significant differences of PD and CAL changes between BCC and ABS groups.

Conclusions: The clinical benefits of BCC were equivalent to ABS and superior to OFD alone. BCC may be an appropriate alternative to conventional graft materials.