A randomized controlled clinical trial evaluating efficacy and adverse events of different types of recombinant human bone morphogenetic protein-2 delivery systems for alveolar ridge preservation.

ABSTRACT

OBJECTIVES: This 12-week clinical trial evaluated efficacy and adverse events for two recombinant human bone morphogenetic protein-2 (rhBMP-2) delivery systems in alveolar ridge preservation. MATERIALS AND METHODS: Sixty-four patients had a single tooth that required replacement with an implant, surrounded by > 50% alveolar bone height. Two cohorts (n = 32 patients each) were randomized to receive a rhBMP-2-soaked absorbable collagen sponge (test group), or ß-tricalcium phosphate and hydroxyapatite particles (control group) immersed in rhBMP-2, at the implant site. Bone height and width changes at 25%, 50%, and 75% of extraction socket level (ESL) were compared. Adverse events were assessed in the same period. In addition to the randomized controlled clinical trial, histological analysis of 21 patients (test group [n = 12], control group [n = 9]) was conducted, 4 months after alveolar ridge preservation. A non-inferiority test was used to analyze changes in alveolar bone height between groups (p = 0.05). A Wilcoxon rank-sum test was used to analyze changes in alveolar bone width and histomorphometric results between groups (p = 0.05). RESULTS: All patients showed good healing without severe adverse events. The lower limit of the one-sided 97.5% confidence interval in the difference between the two groups was 0.0033 (non-inferiority margin -0.185); thus, the test group showed non-inferiority to the control group. Wilcoxon rank-sum test analysis did not show statistically significant differences between groups with regard to changes in alveolar bone width and histomorphometric analysis. CONCLUSIONS: The delivery systems showed similar efficacy for alveolar ridge preservation without severe adverse events.