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 ‡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/P15 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. J Periodontol 2007;78:1855-1863.