Abstract
BackgroundThe aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation.Materials and methodsEighty-four subjects from three centers were enrolled in this clinical trial. After tooth extraction, rhBMP-2/β-TCP (n = 41, test group) or β-TCP (n = 43, control group) were grafted to the extraction socket with an absorbable barrier membrane for alveolar ridge preservation. Using computed tomography images obtained immediately after and 12 weeks after surgery, changes in the alveolar bone height and width were analyzed for each group and compared between the two groups.ResultsBoth the test and control groups showed a significant decrease in alveolar bone height in the 12 weeks after surgery (both groups, p < 0.0001). However, the test group exhibited a significantly lower decrease in alveolar bone height than the control group (p = 0.0004). Alveolar bone width also showed significantly less resorption in the test group than in the control group for all extraction socket levels (ESL) (p = 0.0152 for 75% ESL; p < 0.0001 for 50% ESL; p < 0.0001 for 25% ESL). There were no statistically significant differences in the incidence of adverse events between the two groups. No severe adverse events occurred in either group.ConclusionsThe results of this study suggest that rhBMP-2/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction.Trial registrationClinicaltrials.gov, NCT02714829, Registered 22 March 2016
Highlights
The aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 combined with β-TCP in alveolar ridge preservation
The results of this study suggest that recombinant human bone morphogenetic protein 2 (rhBMP-2)/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction
Of the 86 subjects who completed the clinical trial, 84 subjects were included in the full analysis set (FAS) because two subjects had insufficient data for analyzing the efficacy
Summary
The aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation. The alveolar ridge undergoes normal physiological bone resorption after tooth extraction. In a systematic review by Van der Weijden et al [3], the mean amount of alveolar resorption during the post-extraction healing period was 3.87 mm for width and 1.67–2.03 mm for height. To minimize alveolar bone resorption following tooth extraction and maintain favorable volume and morphology of the alveolar ridge for future restoration, various alveolar ridge preservation (ARP) techniques have been developed and investigated. As an alternative to bone grafting, several investigators have used absorbable collagen sponge (ACS) for the extraction socket with various growth factors and reported comparable treatment outcomes to bone grafts [9, 10]. In a recent systematic review with metaanalysis, Avila-Ortiz et al [11] reported that ARP could reduce vertical and horizontal bone resorption following tooth extraction by 1.72 mm and 1.99 mm, respectively
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