MULTICENTER CLINICAL-EVALUATION OF COMBINATION ANORGANIC BOVINE-DERIVED HYDROXYAPATITE MATRIX (ABM) CELL-BINDING PEPTIDE (P-15) AS A BONE-REPLACEMENT GRAFT MATERIAL IN HUMAN PERIODONTAL OSSEOUS DEFECTS - 6-MONTH RESULTS

A SYNTHETIC CELL-BINDING PEPTIDE (P-15) combined with anorganic bovine -derived hydroxyapatite bone matrix (ABM) was compared to demineralize d freeze-dried bone allograft (DFDBA) and open flap debridement (DEBR) in human periodontal osseous defects in a controlled, monitored, mult i-center trial. Following appropriate initial preparation procedures, flap surgery with defect and root debridement was performed. Three oss eous defects per patient were treated randomly with one of three proce dures after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 to 7 months re-entry flap surgery wa s performed for documentation and finalization of treatment. Analysis of variation (ANOVA) and t test analyses of patient mean values from 3 1 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.8 +/- 1.2 mm (72.3%) versus a mean defect fill of 2.0 +/- 1.4 mm (51.4%) for defects treated with DFDBA (P < 0.05) and a mean defect fill of 1.5 +/- 1.3 mm (40.3%) (P < 0.05) for defects treated with DEER. Other hard tissue findings show ed similar clinically superior results with the use of ABM/P-15. Relat ive defect fill results showed 87% positive (50% to 100% defect fill) responses with ABM/P-15, 58% positive responses with DFDBA, and 41% po sitive responses with DEBR, There were 8 to 9 times more failures (min imal response) with DFDBA and DEBR (26% to 29% frequency) than with AB M/P-15, Soft tissue findings showed no significant differences among t reatments except for greater clinical attachment level gain with ABM/P -15 compared to DEER. These results suggest that the use of the P-15 s ynthetic cell-binding peptide combined with ABM yields better clinical results than either DFDBA or DEER. Further studies are needed to dete rmine the relative roles of the ABM and/or the P-15 in these improved results.