J Adv Prosthodont.  2011 Sep;3(3):161-165. 10.4047/jap.2011.3.3.161.

Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with beta-TCP/HA in extraction socket

• Huh JB
• Lee HJ
• Jang JW
• Kim MJ
• Yun PY
• Kim SH
• Choi KH
• Kim YK
• Cho KS
• Shin SW

• KMID: 2118126
• DOI: http://doi.org/10.4047/jap.2011.3.3.161

Abstract

PURPOSE
This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the beta-TCP bone graft material that contains ErhBMP-2.
MATERIALS AND METHODS
This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes (P<.05).
RESULTS
Changes in alveolar bone height were -1.087 +/- 1.413 mm in the control group and -.059 +/- 0.960 mm in the experimental group (P<.01). At 25% extraction socket length [ESL], the changes were 0.006 +/- 1.149 mm in the control group and 1.279 +/- 1.387 mm in the experimental group. At 50% ESL, the changes were 0.542 +/- 1.157 mm and 1.239 +/- 1.249 mm, respectively (P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed.
CONCLUSION
ErhBMP-2 coated beta-TCP/HA were found to be more effective in preserving alveolar bone than conventional beta-TCP/HA alloplastic bone graft materials.

Keyword

ErhBMP-2; beta-TCP/HA; Tooth extraction; Alveolar bone regeneration; Randomized clinical trial

MeSH Terms

Bone Regeneration
Calcium Phosphates
Escherichia
Humans
Tooth Extraction
Transplants
Calcium Phosphates

Figure

• 

  Fig. 1 Computed tomography (CT) height and width measurements at baseline before tooth extraction (A) and 3 months after transplantation (B). (1) Point a was marked on the same point of the lower edge of the mandible on representative CT scans taken before and after transplantation. (2) Points b and c were marked at the most prominent points on the buccal and lingual aspects, respectively. (3) Line A connected points b and c. (4) Line B, the "axial line", connected the midpoint between points b and c, which was called (5) Line C was drawn perpendicular to the "axial line"from the most superior point of the alveolar bone. (6) Bone height was defined as the distance between point d and line C. (7) The distance between point d and line C was divided into 4 aliquot portions and bone width was measured on each line before and after transplantation.

• 

  Fig. 2 Computed tomography views at baseline following tooth extraction (A, C) and 3 months post-treatment (B, D). In the control group, there was resorption of the buccal plate and reduction in bone width. However, in the experimental group, the buccal plate was maintained and bone width increased (white arrow). ((A) at post-treatment following tooth extraction in the control group, (B) after 3 months in the control group (C) at post-treatment following tooth extraction in the experiment group, (D) after 3 months in the experiment group).

Reference

1. Tallgren A, Lang BR, Walker GF, Ash MM Jr. Roentgen cephalometric analysis of ridge resorption and changes in jaw and occlusal relationships in immediate complete denture wearers. J Oral Rehabil. 1980. 7:77–94.

2. Jackson BJ, Morcos I. Socket grafting: a predictable technique for site preservation. J Oral Implantol. 2007. 33:353–364.

3. John V, De Poi R, Blanchard S. Socket preservation as a precursor of future implant placement: review of the literature and case reports. Compend Contin Educ Dent. 2007. 28:646–653.

4. Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003. 8:227–265.

5. Szpalski M, Gunzburg R. Applications of calcium phosphate-based cancellous bone void fillers in trauma surgery. Orthopedics. 2002. 25:s601–s609.

6. Urist MR, Lietze A, Dawson E. Beta-tricalcium phosphate delivery system for bone morphogenetic protein. Clin Orthop Relat Res. 1984. 187:277–280.

7. Urist MR. Bone: formation by autoinduction. Science. 1965. 150:893–899.

8. Bessa PC, Casal M, Reis RL. Bone morphogenetic proteins in tissue engineering: the road from the laboratory to the clinic, part I (basic concepts). J Tissue Eng Regen Med. 2008. 2:1–13.

9. Bessa PC, Casal M, Reis RL. Bone morphogenetic proteins in tissue engineering: the road from laboratory to clinic, part II (BMP delivery). J Tissue Eng Regen Med. 2008. 2:81–96.

10. Wang EA, Rosen V, D'Alessandro JS, Bauduy M, Cordes P, Harada T, Israel DI, Hewick RM, Kerns KM, LaPan P, Luxenberg DP, McQuaid D, Moutsatsos IK, Nove J, Wozney JM. Recombinant human bone morphogenetic protein induces bone formation. Proc Natl Acad Sci USA. 1990. 87:2220–2224.

11. Israel DI, Nove J, Kerns KM, Kaufman RJ, Rosen V, Cox KA, Wozney JM. Heterodimeric bone morphogenetic proteins show enhanced activity in vitro and in vivo. Growth Factors. 1996. 13:291–300.

12. Friedlaender GE, Perry CR, Cole JD, Cook SD, Cierny G, Muschler GF, Zych GA, Calhoun JH, LaForte AJ, Yin S. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions. J Bone Joint Surg Am. 2001. 83-A:S151–S158.

13. Burkus JK, Heim SE, Gornet MF, Zdeblick TA. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J Spinal Disord Tech. 2003. 16:113–122.

14. Bessho K, Konishi Y, Kaihara S, Fujimura K, Okubo Y, Iizuka T. Bone induction by Escherichia coli -derived recombinant human bone morphogenetic protein-2 compared with Chinese hamster ovary cell-derived recombinant human bone morphogenetic protein-2. Br J Oral Maxillofac Surg. 2000. 38:645–649.

15. Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005. 76:605–613.

16. Einhorn TA, Majeska RJ, Mohaideen A, Kagel EM, Bouxsein ML, Turek TJ, Wozney JM. A single percutaneous injection of recombinant human bone morphogenetic protein-2 accelerates fracture repair. J Bone Joint Surg Am. 2003. 85-A:1425–1435.

17. Cochran DL, Jones AA, Lilly LC, Fiorellini JP, Howell H. Evaluation of recombinant human bone morphogenetic protein-2 in oral applications including the use of endosseous implants: 3-year results of a pilot study in humans. J Periodontol. 2000. 71:1241–1257.

18. Howell TH, Fiorellini J, Jones A, Alder M, Nummikoski P, Lazaro M, Lilly L, Cochran D. A feasibility study evaluating rhBMP-2/absorbable collagen sponge device for local alveolar ridge preservation or augmentation. Int J Periodontics Restorative Dent. 1997. 17:124–139.