Clinical Evaluation of a Biphasic Calcium Composite Grafting Material in the Treatment of Human Periodontal Intrabony Defects: A 12‐Month Randomized Controlled Clinical Trial
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Media type:
E-Article
Title:
Clinical Evaluation of a Biphasic Calcium Composite Grafting Material in the Treatment of Human Periodontal Intrabony Defects: A 12‐Month Randomized Controlled Clinical Trial
Description:
<jats:p><jats:bold>Background:</jats:bold> 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.</jats:p><jats:p><jats:bold>Methods:</jats:bold> Forty‐five subjects with at least one intrabony defect with a probing depth (PD) ≥7 mm and a vertical radiographic bone loss ≥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.</jats:p><jats:p><jats:bold>Results:</jats:bold> In all treatment groups, significant PD reductions and CAL gains occurred during the study period (<jats:italic>P</jats:italic> <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 (<jats:italic>P</jats:italic> = 0.002) and ABS (<jats:italic>P</jats:italic> = 0.001). The additional PD reduction was significant for the BCC group (<jats:italic>P</jats:italic> = 0.011) and borderline significant for the ABS group (<jats:italic>P</jats:italic> = 0.059). There were no significant differences of PD and CAL changes between BCC and ABS groups.</jats:p><jats:p><jats:bold>Conclusions:</jats:bold> The clinical benefits of BCC were equivalent to ABS and superior to OFD alone. BCC may be an appropriate alternative to conventional graft materials.</jats:p>