Clinical evaluation of the combination of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (P-15) in particulate and hydrogel form as a bone replacement graft material in human periodontal osseous defects: 6-month reentry controlled clinical study.

BACKGROUND

This prospective, randomized, controlled clinical trial study compared the clinical outcomes of the biomaterial anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) as a biocompatible hydrogel carrier consisting of carboxymethylcellulose and glycerol or in particulate form when used as a bone replacement graft in the treatment of human periodontal infrabony defects.

METHODS

Nineteen patients with advanced chronic periodontitis were recruited. All patients had at least two non-adjacent intrabony osseous defects > or = 3 mm after completion of cause-related periodontal therapy. The surgical procedures included access flaps for root instrumentation and filling the defect with ABM/P-15 in hydrogel or particulate form. Reentry access flap surgery was performed at 6 months. Changes in soft and hard tissue outcome measurements between baseline and 6 months were evaluated in all defects.

RESULTS

At 6 months, no significant differences between ABM/P-15 hydrogel and ABM/P-15 particulate were demonstrated for the amount of defect fill (3.10 +/- 0.85 mm [75.0%] versus 3.09 +/- 1.11 mm [73.7%], respectively) or defect resolution (85.8% versus 81.9%). Changes in soft tissue clinical outcomes did not show significant differences between the treatments.

CONCLUSION

This trial failed to demonstrate superiority of the novel ABM/P-15 hydrogel therapeutic modality over the standard ABM/ P-15 particulate graft in the treatment of intrabony periodontal defects.