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Journal of Periodontology
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August 2000, Vol. 71, No. 8, Pages 1241-1257 https://doi.org/10.1902/jop.2000.71.8.1241
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 Dr. David L. Cochran
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Department of Periodontics, University of Texas Health Science Center at San Antonio, San Antonio, TX.
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Archie A. Jones Department of Periodontics, University of Texas Health Science Center at San Antonio, San Antonio, TX. Leslie Clark Lilly Genetics Institute, Cambridge, MA. Joseph P. Fiorellini
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Harvard School of Dental Medicine, Boston, MA.
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Howard Howell
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Harvard School of Dental Medicine, Boston, MA.
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Background: This study evaluated patients who had been treated with recombinant human bone morphogenetic protein-2 (rhBMP-2) loaded in an absorbable collagen sponge (ACS) in human extraction sites or in sites that required alveolar ridge augmentation. An earlier report on the same patients revealed that after 4 months, implantation of rhBMP-2/ACS was safe, as determined by clinical, radiographic, systemic, and immunological analyses. In this longer-term followup, eligible patients were restored with endosseous dental implants in the area treated with rhBMP-2/ACS and bone biopsy samples were taken for histological analysis of the treated human bone tissue. The primary objective was to monitor the long-term safety of patients treated with rhBMP-2/ACS. Another objective was to evaluate the dental implants placed in the sites treated with rhBMP-2.
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Methods: Patient safety was evaluated by clinical examinations, periapical radiographs, and occurrence of adverse experiences. Dental implants were evaluated by radiographic and clinical examination. All 12 patients have been followed for 3 years.
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Results: Two years following surgical implantation of rhBMP-2/ACS, no serious or unexpected adverse experiences occurred. The adverse experiences that did occur were mostly benign and compatible with the dental implant surgeries performed in these patients. No adverse experiences were deemed as related to the rhBMP-2/ACS. Furthermore, no safety concerns in the local area of rhBMP-2/ACS placement were noted, based on oral wound examinations. In the 10 patients (6 extraction socket patients and 4 augmentation patients) who received endosseous implants, all implants were clinically stable at all assessments and all 10 patients have been functionally restored. Histological evaluation of the human bone core biopsies revealed normal bone tissue formation identical to the surrounding native bone. Three-year follow-up clinical examinations revealed that all implants had stable marginal bone levels and healthy peri-implant tissues.
Dr. David L. Cochran Archie A. Jones Leslie Clark Lilly Joseph P. Fiorellini Howard Howell
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Conclusions: These 3-year results demonstrate that rhBMP-2/ACS can be used safely in human patients. Human bone biopsies reveal normal bone formation in areas treated with rhBMP-2/ACS. Endosseous implants placed in these areas were all stable with no radiographic or clinical complications. The results from this study suggest that rhBMP-2/ACS (0.43 mg/ml) can be safely used in tooth extraction sites and in local ridge augmentation procedures and that endosseous dental implants placed in bony areas treated with rhBMP-2/ACS are stable and can be functionally restored without complication. J Periodontol 2000;71:1241-1257.
Protein, bone morphogenetic dental implants, endosseous
KEYWORDS: Protein, bone morphogenetic, dental implants, endosseous, growth factors, protein, differentiation, protein, recombinant, tooth extraction, followup studies, clinical trials
growth factors protein, differentiation
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protein, recombinant
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follow-up studies
tooth extraction clinical trials
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(2006) The Effect of rhBMP-2 Around Endosseous Implants With and Without Membranes in the Canine Model. Journal of Periodontology 77:7, 1184-1193. Online publication date: 20-Jun-2006. Abstract | Full Text | PDF (18643 KB) | PDF Plus (368 KB) Ichiro Seto, Eriko Marukawa and Izumi Asahina. (2006) Mandibular Reconstruction Using a Combination Graft of rhBMP-2 with Bone Marrow Cells Expanded In Vitro. Plastic and Reconstructive Surgery 117:3, 902-908. Online publication date: 1-Mar-2006. Crossref Ziv Simon, Douglas A. Deporter, Robert M. Pilliar and Cameron M. Clokie. (2006) Heterotopic Bone Formation Around Sintered Porous-Surfaced Ti-6Al-4V Implants Coated with Native Bone Morphogenetic Proteins. Implant Dentistry 15:3, 265-274. Online publication date: 1-Jan-2006. Crossref Karl-Heinz Schuckert, Stefan Jopp and Ulrich Muller. (2006) De Novo Grown Bone on Exposed Implant Surfaces Using Photodynamic Therapy and Recombinant Human Bone Morphogenetic Protein-2: Case Report. Implant Dentistry 15:4, 361-365. Online publication date: 1-Jan-2006. Crossref RP Nacamuli and MT Longaker. (2005) Bone induction in craniofacial defects1. Orthodontics and Craniofacial Research 8:4, 259-266. Online publication date: 1-Nov-2005. Crossref Gianmario Schierano, Rosa Angela Canuto, Roberto Navone, Bruno Peirone, Germana Martinasso, Marco Pagano, Marina Maggiora, Carlo Manzella, Michael Easton, Annalisa Davit, Antonella Trombetta, Stefano Amedeo, Bartolomeo Biolatti, Stefano Carossa and Giulio Preti. (2005) Biological Factors Involved in the Osseointegration of Oral Titanium Implants With Different Surfaces: A Pilot Study in Minipigs. Journal of Periodontology 76:10, 1710-1720. Online publication date: 27-Oct-2005. Abstract | PDF (133663 KB) | PDF Plus (1955 KB) J.M. Granjeiro, R.C. Oliveira, J.C. Bustos-Valenzuela, M.C. Sogayar and R. Taga. (2005) Bone morphogenetic proteins: from structure to clinical use. Brazilian Journal of Medical and Biological Research 38:10, 1463-1473. Online publication date: 1-Oct-2005. Crossref Ming Zhao, Zhuoran Zhao, Jeong-Tae Koh, Taocong Jin and Renny T. Franceschi. (2005) Combinatorial gene therapy for bone regeneration: Cooperative interactions between adenovirus vectors expressing bone morphogenetic proteins 2, 4, and 7. Journal of Cellular Biochemistry 95:1, 1-16. Online publication date: 1-Jan-2005. Crossref Dr. Joseph P. Fiorellini , T. Howard Howell , David Cochran , Jay Malmquist , Leslie C. Lilly , Daniel Spagnoli , Joseph Toljanic , Archie Jones and Myron Nevins . (2005) Randomized Study Evaluating Recombinant Human Bone Morphogenetic Protein-2 for Extraction Socket Augmentation. Journal of Periodontology 76:4, 605-613. Online publication date: 27-Apr-2005. Abstract | PDF (6391 KB) | PDF Plus (345 KB) James D. Kassolis and Mark A. Reynolds. (2005) Evaluation of the Adjunctive Benefits of Platelet-Rich Plasma in Subantral Sinus Augmentation. Journal of Craniofacial Surgery 16:2, 280-287. Online publication date: 1-Mar-2005. Crossref Paul J Harwood and Peter V Giannoudis. (2005) Application of bone morphogenetic proteins in orthopaedic practice: their efficacy and side effects. Expert Opinion on Drug Safety 4:1, 75-89. Online publication date: 1-Jan-2005. Crossref Dr. Adi Rachmiel , Dror Aizenbud and Micha Peled . (2004) Enhancement of Bone Formation by Bone Morphogenetic Protein-2 During Alveolar Distraction: An Experimental Study in Sheep. Journal of Periodontology 75:11, 1524-1531. Online publication date: 17-Feb-2005. Abstract | PDF (5858 KB) | PDF Plus (563 KB) J Jadlowiec, C Sfeir, P Campbell and H Koch. 2004. Signaling Molecules for Tissue Engineering. Bone Tissue Engineering, 125-147. Crossref Yun-Ying Shi, Randall P. Nacamuli and Michael T. Longaker. (2004) Intermittent Parathyroid Hormone Treatment Enhances Guided Bone Regeneration in Rat Calvarial Bone Defects.. Journal of Craniofacial Surgery 15:3, 428-430. Online publication date: 1-May-2004. Crossref P. Arpornmaeklong, M. Kochel, R. Depprich, N.R. Kübler and K.K. Würzler. (2004) Influence of platelet-rich plasma (PRP) on osteogenic differentiation of rat bone marrow stromal cells. An in vitro study. International Journal of Oral and Maxillofacial Surgery 33:1, 60-70. Online publication date: 1-Feb-2004. Crossref Joseph P. Fiorellini and Marc L. Nevins . (2003) Localized Ridge Augmentation/Preservation.A Systematic Review. Annals of Periodontology 8:1, 321-327. Online publication date: 11-Jan-2005. Abstract | PDF (82 KB) | PDF Plus (103 KB) William V. Giannobile and Martha J. Somerman . (2003) Growth and Amelogenin-Like Factors in Periodontal Wound Healing. A Systematic Review. Annals of Periodontology 8:1, 193-204. Online publication date: 11-Jan-2005. Abstract | PDF (208 KB) | PDF Plus (236 KB) Dr. Yong-Moo Lee , Sung-Heon Nam , Yang-Jo Seol , Tae-Il Kim , Seung-Jin Lee , Young Ku , In-Chul Rhyu , Chong-Pyoung Chung , Soo-Boo Han and SangMook Choi . (2003) Enhanced Bone Augmentation by Controlled Release of Recombinant Human Bone Morphogenetic Protein-2 from Bioabsorbable Membranes. Journal of Periodontology 74:6, 865-872. Online publication date: 11-Jan-2005. Abstract | PDF (786 KB) | PDF Plus (381 KB) Seong-Hee Ahn , Chang-Sung Kim , Hun-Joo Suk , Yong-Jun Lee , Seong-Ho Choi , Jung-Kiu Chai , Chong-Kwan Kim , Soo-Boo Han and Dr. Kyoo-Sung Cho . (2003) Effect of Recombinant Human Bone Morphogenetic Protein-4 with Carriers in Rat Calvarial Defects. Journal of Periodontology 74:6, 787-797. Online publication date: 11-Jan-2005. Abstract | PDF (1053 KB) | PDF Plus (501 KB) Julie A Jadlowiec, Ayse B Celil and Jeffrey O Hollinger. (2003) Bone tissue engineering:recent advances and promising therapeutic agents. Expert Opinion on Biological Therapy 3:3, 409-423. Online publication date: 23-May-2015. Crossref Oliver Hanisch , Rachel G. Sorensen , Atsuhiro Kinoshita , Hubertus Spiekermann , John M. Wozney and Dr. Ulf M.E. Wikesjö . (2003) Effect of Recombinant Human Bone Morphogenetic Protein-2 in Dehiscence Defects with Non-Submerged Immediate Implants: An Experimental Study in Cynomolgus Monkeys. Journal of Periodontology 74:5, 648-657. Online publication date: 11-Jan-2005. Abstract | PDF (10813 KB) | PDF Plus (619 KB) Jennifer Wong and Michael Paine. 2003. Osteoblast Response to Pure Titanium and Titanium Alloy. Bio-Implant Interface. Crossref Q-M. Jin , O. Anusaksathien , S.A. Webb , R.B. Rutherford and Dr. W.V. Giannobile . (2003) Gene Therapy of Bone Morphogenetic Protein for Periodontal Tissue Engineering. Journal of Periodontology 74:2, 202-213. Online publication date: 11-Jan-2005. Abstract | PDF (26099 KB) | PDF Plus (887 KB) Ulf M.E. Wikesjo, Andreas V. Xiropaidis, Robert C. Thomson, Alonzo D. Cook, Knut A. Selvig and W. Ross Hardwick. (2003) Periodontal repair in dogs: spaceproviding ePTFE devices increase rhBMP-2/ACS-induced bone formation. Journal of Clinical Periodontology 30:8, 715. Crossref Ashley R. Poynton and Joseph M. Lane. (2002) Safety Profile for the Clinical Use of Bone Morphogenetic Proteins in the Spine. Spine 27:Supplement, S40S48. Online publication date: 1-Aug-2002. Crossref E. Marukawa, I. Asahina, M. Oda, I. Seto, Md. Alam and S. Enomoto. (2002) Functional reconstruction of the non-human primate mandible using recombinant human bone morphogenetic protein-2. International Journal of Oral and Maxillofacial Surgery 31:3, 287-295. Online publication date: 1-Jun-2002. Crossref Luiz A. Salata, Victoria Franke-Stenport and Lars Rasmusson. (2002) Recent Outcomes and Perspectives of the Application of Bone Morphogenetic Proteins in Implant Dentistry. Clinical Implant Dentistry and Related Research 4:1, 27-32. Online publication date: 1-Jan-2002. Crossref Ichiro Seto, Noriko Tachikawa, Masaji Mori, Satoru Hoshino, Eriko Marukawa, Izumi Asahina and Shoji Enomoto. (2002) Restoration of occlusal function using osseointegrated implants in the canine mandible reconstructed by rhBMP-2. Clinical Oral Implants Research 13:5, 536. Crossref Kodi Azari, Bruce A Doll, Charles Sfeir, Ying Mu and Jeffrey O Hollinger. (2001) Therapeutic potential of bone morphogenetic proteins. Expert Opinion on Investigational Drugs 10:9, 1677-1686. Online publication date: 24-Feb-2005. Crossref Chi H. Lee, Anuj Singla and Yugyung Lee. (2001) Biomedical applications of collagen. International Journal of Pharmaceutics 221:1-2, 1-22. Online publication date: 1-Jun-2001. Crossref Sébastien A. Gittens and Hasan Uludag. (2001) Growth Factor Delivery for Bone Tissue Engineering. Journal of Drug Targeting 9:6, 407-429. Online publication date: 1-Jan-2001. Crossref The Research, Science and Therapy Committee of the American Academy of Periodontology. (2000) Position Paper Dental Implants in Periodontal Therapy. Journal of Periodontology 71:12, 1934-1942. Online publication date: 12-Jan-2005. Abstract | PDF (92 KB) | PDF Plus (184 KB) Julia Zimmer, Elisa Degenkolbe, Britt Wildemann and Petra Seemann. BMP Signaling in Regenerative Medicine. Bioinformatics, 1252-1281. Crossref Julia Zimmer, Elisa Degenkolbe, Britt Wildemann and Petra Seemann. BMP Signaling in Regenerative Medicine. Medical Advancements in Aging and Regenerative Technologies, 1-30. Crossref PDF (4781 KB) PDF Plus (453 KB) © 2017 American Academy of Periodontology. All rights reserved. Disclaimers apply | Privacy commitment | Contact AAP
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