De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation

Philip J. Boyne, Leslie C. Lilly, Robert Marx, Peter K. Moy, Myron Nevins, Daniel B. Spagnoli, R. Gilbert Triplett

Research output: Contribution to journalArticle

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Abstract

Purpose: This phase II study was designed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation. Materials and Methods: Patients were treated with rhBMP-2 (via an absorbable collagen sponge [ACS]), at concentrations of 0.75 mg/mL (n = 18), 1.50 mg/mL (n = 17), or with bone graft (n = 13). Bone induction was assessed by alveolar ridge height, width, and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants (density only). Results: Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups; 11.3 mm, 9.5 mm, and 10.2 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups. Mean increases in alveolar ridge width (buccal to lingual) at the crest of the ridge were statistically different among the treatment groups; 4.7 mm, 2.0 mm, and 2.0 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL treatment groups (P ≤ .01 vs 0.75 mg/mL; P < .01 vs 1.50 mg/mL). At 4 months postoperative new bone density was statistically different among the treatment groups; 350 mg/cc, 84 mg/cc, and 134 mg/cc for the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively (P = .003 vs 0.75 mg/mL, P = .0137 vs 1.50 mg/mL, P = .0188; 1.50 mg/mL vs 0.75 mg/mL). Core bone biopsies obtained at the time of dental implant placement confirmed normal bone formation. The proportion of patients who received dental implants that were functionally loaded and remained functional at 36 months post-functional loading was 62%, 67%, and 76% in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively. Conclusion: This study is the first randomized controlled trial demonstrating de novo organ tissue growth in humans from a recombinant human protein. rhBMP-2/ACS safely induced adequate bone for the placement and functional loading of endosseous dental implants in patients requiring staged maxillary sinus floor augmentation.

Original languageEnglish
Pages (from-to)1693-1707
Number of pages15
JournalJournal of Oral and Maxillofacial Surgery
Volume63
Issue number12
DOIs
StatePublished - Dec 1 2005

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Sinus Floor Augmentation
Dental Implants
Bone and Bones
Porifera
Collagen
Alveolar Process
Transplants
Therapeutics
recombinant human bone morphogenetic protein-2
Cheek
Tongue
Recombinant Proteins
Osteogenesis
Bone Density
Randomized Controlled Trials

ASJC Scopus subject areas

  • Dentistry(all)
  • Surgery

Cite this

De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. / Boyne, Philip J.; Lilly, Leslie C.; Marx, Robert; Moy, Peter K.; Nevins, Myron; Spagnoli, Daniel B.; Triplett, R. Gilbert.

In: Journal of Oral and Maxillofacial Surgery, Vol. 63, No. 12, 01.12.2005, p. 1693-1707.

Research output: Contribution to journalArticle

Boyne, Philip J. ; Lilly, Leslie C. ; Marx, Robert ; Moy, Peter K. ; Nevins, Myron ; Spagnoli, Daniel B. ; Triplett, R. Gilbert. / De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. In: Journal of Oral and Maxillofacial Surgery. 2005 ; Vol. 63, No. 12. pp. 1693-1707.
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abstract = "Purpose: This phase II study was designed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation. Materials and Methods: Patients were treated with rhBMP-2 (via an absorbable collagen sponge [ACS]), at concentrations of 0.75 mg/mL (n = 18), 1.50 mg/mL (n = 17), or with bone graft (n = 13). Bone induction was assessed by alveolar ridge height, width, and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants (density only). Results: Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups; 11.3 mm, 9.5 mm, and 10.2 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups. Mean increases in alveolar ridge width (buccal to lingual) at the crest of the ridge were statistically different among the treatment groups; 4.7 mm, 2.0 mm, and 2.0 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL treatment groups (P ≤ .01 vs 0.75 mg/mL; P < .01 vs 1.50 mg/mL). At 4 months postoperative new bone density was statistically different among the treatment groups; 350 mg/cc, 84 mg/cc, and 134 mg/cc for the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively (P = .003 vs 0.75 mg/mL, P = .0137 vs 1.50 mg/mL, P = .0188; 1.50 mg/mL vs 0.75 mg/mL). Core bone biopsies obtained at the time of dental implant placement confirmed normal bone formation. The proportion of patients who received dental implants that were functionally loaded and remained functional at 36 months post-functional loading was 62{\%}, 67{\%}, and 76{\%} in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively. Conclusion: This study is the first randomized controlled trial demonstrating de novo organ tissue growth in humans from a recombinant human protein. rhBMP-2/ACS safely induced adequate bone for the placement and functional loading of endosseous dental implants in patients requiring staged maxillary sinus floor augmentation.",
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AU - Marx, Robert

AU - Moy, Peter K.

AU - Nevins, Myron

AU - Spagnoli, Daniel B.

AU - Triplett, R. Gilbert

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N2 - Purpose: This phase II study was designed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation. Materials and Methods: Patients were treated with rhBMP-2 (via an absorbable collagen sponge [ACS]), at concentrations of 0.75 mg/mL (n = 18), 1.50 mg/mL (n = 17), or with bone graft (n = 13). Bone induction was assessed by alveolar ridge height, width, and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants (density only). Results: Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups; 11.3 mm, 9.5 mm, and 10.2 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups. Mean increases in alveolar ridge width (buccal to lingual) at the crest of the ridge were statistically different among the treatment groups; 4.7 mm, 2.0 mm, and 2.0 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL treatment groups (P ≤ .01 vs 0.75 mg/mL; P < .01 vs 1.50 mg/mL). At 4 months postoperative new bone density was statistically different among the treatment groups; 350 mg/cc, 84 mg/cc, and 134 mg/cc for the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively (P = .003 vs 0.75 mg/mL, P = .0137 vs 1.50 mg/mL, P = .0188; 1.50 mg/mL vs 0.75 mg/mL). Core bone biopsies obtained at the time of dental implant placement confirmed normal bone formation. The proportion of patients who received dental implants that were functionally loaded and remained functional at 36 months post-functional loading was 62%, 67%, and 76% in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively. Conclusion: This study is the first randomized controlled trial demonstrating de novo organ tissue growth in humans from a recombinant human protein. rhBMP-2/ACS safely induced adequate bone for the placement and functional loading of endosseous dental implants in patients requiring staged maxillary sinus floor augmentation.

AB - Purpose: This phase II study was designed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation. Materials and Methods: Patients were treated with rhBMP-2 (via an absorbable collagen sponge [ACS]), at concentrations of 0.75 mg/mL (n = 18), 1.50 mg/mL (n = 17), or with bone graft (n = 13). Bone induction was assessed by alveolar ridge height, width, and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants (density only). Results: Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups; 11.3 mm, 9.5 mm, and 10.2 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups. Mean increases in alveolar ridge width (buccal to lingual) at the crest of the ridge were statistically different among the treatment groups; 4.7 mm, 2.0 mm, and 2.0 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL treatment groups (P ≤ .01 vs 0.75 mg/mL; P < .01 vs 1.50 mg/mL). At 4 months postoperative new bone density was statistically different among the treatment groups; 350 mg/cc, 84 mg/cc, and 134 mg/cc for the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively (P = .003 vs 0.75 mg/mL, P = .0137 vs 1.50 mg/mL, P = .0188; 1.50 mg/mL vs 0.75 mg/mL). Core bone biopsies obtained at the time of dental implant placement confirmed normal bone formation. The proportion of patients who received dental implants that were functionally loaded and remained functional at 36 months post-functional loading was 62%, 67%, and 76% in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively. Conclusion: This study is the first randomized controlled trial demonstrating de novo organ tissue growth in humans from a recombinant human protein. rhBMP-2/ACS safely induced adequate bone for the placement and functional loading of endosseous dental implants in patients requiring staged maxillary sinus floor augmentation.

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