Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

Abstract

Background: 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.

Materials and methods: Eighty-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.

Results: Both 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.

Conclusions: The 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 registration: Clinicaltrials.gov , NCT02714829 , Registered 22 March 2016.

Keywords: Alveolar ridge preservation; Clinical trial; Socket preservation; rhBMP-2; β-TCP.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1

Schematic diagram of the protocol in the clinical trial

Fig. 2

rhBMP-2/β-TCP used in this study. A Field emission scanning electron microscope image of β-TCP (x 200) B Carrier part including syringe containing 1.5 g of β-TCP, empty, unused syringe, connector and syringe tip C recombinant human BMP-2 part including E. coli-derived rhBMP-2 powder and water for injection

Fig. 3

Surgical procedures performed in this study. A Initial clinical photograph. B After extraction. C, D, and E Application of the grafted material into the extraction socket up to the crestal level of the remaining alveolar bone (rhBMP-2/ β-TCP for test group and β-TCP for control group)

Fig. 4

Landmarks and linear measurement parameters used to evaluate changes in the alveolar bone height and width in this study (A, immediately after surgery; B, 6 months after ARP). Line A was the line passing through points a and b, where points a and b were defined as the most superior point of the lingual and buccal alveolar bone, respectively. Point c was the point that bisects line A, and point d was the apex of the extraction socket. The line passing through points c and d was defined as line B. Line C was set as the line perpendicular to line B and passing through point d. The height of the alveolar bone immediately after surgery was measured as the distance from point c to point d. The width of the alveolar bone was measured at the points where the alveolar bone height was divided into quarters. To measure the changes of the alveolar ridge 12 weeks after surgery, the reference lines B and C, reference lines for 25%, 50%, and 75% ESL, and point d were transferred to the CT images taken 12 weeks after surgery. Point a’ and b’ were marked as the most superior point of the lingual and buccal alveolar bone, and line A’ was defined as the line passing through points a’ and b’. Point c’ was the intersection of line A’ and line B. By measuring the distance from point c’ to point d, the alveolar bone height at 12 weeks after surgery was measured. The width of the alveolar bone was measured at the points where the alveolar bone height was divided into quarters

Fig. 5

Flow diagram of a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial of rhBMP-2/β-TCP (test group) for alveolar ridge preservation in alveolar ridge preservation compared with β-TCP (control group)

Fig. 6

Computed tomography images for efficacy assessment. Test group (A, immediately postoperative; B, 12 weeks after surgery) showed a better alveolar ridge preservation effect at 12 weeks after surgery than the control group (C, immediately postoperative; D, 12 weeks after surgery)