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/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.