Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation

R. Gilbert Triplett, Myron Nevins, Robert Marx, Daniel B. Spagnoli, Thomas W. Oates, Peter K. Moy, Philip J. Boyne

Research output: Contribution to journalArticle

179 Citations (Scopus)

Abstract

Purpose: The purpose of this prospective study was to evaluate the safety and effectiveness of recombinant human morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) compared with an autogenous bone graft when used for 2-stage maxillary sinus floor augmentation. The study assessed new bone formation, placement integration, and functional loading after 6 months and long term for 2 years. Materials and Methods: A total of 160 subjects were randomized, enrolled, and followed from January 1999 to February 2004 at 21 centers in the United States. The subjects with less than 6 mm of native bone height were treated with 1.50 mg/mL rhBMP-2/ACS or with an autograft. The height and density measurements were quantified by computed tomography scans. Core biopsies were obtained at dental implant placement and used for histological analysis. Safety was evaluated by oral examinations, radiographs, serum chemistries, and hematology. Results: A significant amount of new bone was formed by 6 months postoperatively in each group. The mean change in bone height in the rhBMP-2/ACS subjects was 7.83 ± 3.52 mm versus 9.46 ± 4.11 mm for the bone graft subjects. At 6 months after dental restoration, the induced bone in the rhBMP-2/ACS group was significantly denser than that in the bone graft group. No marked differences were found in the histologic parameters evaluated between the 2 groups. The new bone was comparable to the native bone in density and structure in both groups. The success rate for the rhBMP-2/ACS group was 79% (64 of 81 subjects), and 201 of 251 implants placed in the bone graft group and 199 of 241 implants placed in the rhBMP-2/ACS group were integrated, retained, and functional at 6 months after loading. No adverse events were deemed related to the rhBMP-2/ACS treatment. The autograft group was noted to have a 17% rate of long-term parasthesia, pain, or gait disturbance related to the bone graft harvest. Conclusions: The results of our multicenter, randomized, prospective, clinical trial have shown the effectiveness and safety of rhBMP-2/ACS compared with bone graft for sinus floor augmentation. The study's primary endpoint was exceeded, and the implants placed in rhBMP-2/ACS and bone graft groups performed similarly after functional loading.

Original languageEnglish
Pages (from-to)1947-1960
Number of pages14
JournalJournal of Oral and Maxillofacial Surgery
Volume67
Issue number9
DOIs
StatePublished - Sep 1 2009

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Sinus Floor Augmentation
Porifera
Collagen
Transplants
Bone and Bones
Autografts
Safety
recombinant human bone morphogenetic protein-2
Oral Diagnosis
Dental Implants
Hematology
Gait

ASJC Scopus subject areas

  • Oral Surgery
  • Otorhinolaryngology
  • Surgery

Cite this

Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation. / Triplett, R. Gilbert; Nevins, Myron; Marx, Robert; Spagnoli, Daniel B.; Oates, Thomas W.; Moy, Peter K.; Boyne, Philip J.

In: Journal of Oral and Maxillofacial Surgery, Vol. 67, No. 9, 01.09.2009, p. 1947-1960.

Research output: Contribution to journalArticle

Triplett, R. Gilbert ; Nevins, Myron ; Marx, Robert ; Spagnoli, Daniel B. ; Oates, Thomas W. ; Moy, Peter K. ; Boyne, Philip J. / Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation. In: Journal of Oral and Maxillofacial Surgery. 2009 ; Vol. 67, No. 9. pp. 1947-1960.
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abstract = "Purpose: The purpose of this prospective study was to evaluate the safety and effectiveness of recombinant human morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) compared with an autogenous bone graft when used for 2-stage maxillary sinus floor augmentation. The study assessed new bone formation, placement integration, and functional loading after 6 months and long term for 2 years. Materials and Methods: A total of 160 subjects were randomized, enrolled, and followed from January 1999 to February 2004 at 21 centers in the United States. The subjects with less than 6 mm of native bone height were treated with 1.50 mg/mL rhBMP-2/ACS or with an autograft. The height and density measurements were quantified by computed tomography scans. Core biopsies were obtained at dental implant placement and used for histological analysis. Safety was evaluated by oral examinations, radiographs, serum chemistries, and hematology. Results: A significant amount of new bone was formed by 6 months postoperatively in each group. The mean change in bone height in the rhBMP-2/ACS subjects was 7.83 ± 3.52 mm versus 9.46 ± 4.11 mm for the bone graft subjects. At 6 months after dental restoration, the induced bone in the rhBMP-2/ACS group was significantly denser than that in the bone graft group. No marked differences were found in the histologic parameters evaluated between the 2 groups. The new bone was comparable to the native bone in density and structure in both groups. The success rate for the rhBMP-2/ACS group was 79{\%} (64 of 81 subjects), and 201 of 251 implants placed in the bone graft group and 199 of 241 implants placed in the rhBMP-2/ACS group were integrated, retained, and functional at 6 months after loading. No adverse events were deemed related to the rhBMP-2/ACS treatment. The autograft group was noted to have a 17{\%} rate of long-term parasthesia, pain, or gait disturbance related to the bone graft harvest. Conclusions: The results of our multicenter, randomized, prospective, clinical trial have shown the effectiveness and safety of rhBMP-2/ACS compared with bone graft for sinus floor augmentation. The study's primary endpoint was exceeded, and the implants placed in rhBMP-2/ACS and bone graft groups performed similarly after functional loading.",
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AU - Marx, Robert

AU - Spagnoli, Daniel B.

AU - Oates, Thomas W.

AU - Moy, Peter K.

AU - Boyne, Philip J.

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N2 - Purpose: The purpose of this prospective study was to evaluate the safety and effectiveness of recombinant human morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) compared with an autogenous bone graft when used for 2-stage maxillary sinus floor augmentation. The study assessed new bone formation, placement integration, and functional loading after 6 months and long term for 2 years. Materials and Methods: A total of 160 subjects were randomized, enrolled, and followed from January 1999 to February 2004 at 21 centers in the United States. The subjects with less than 6 mm of native bone height were treated with 1.50 mg/mL rhBMP-2/ACS or with an autograft. The height and density measurements were quantified by computed tomography scans. Core biopsies were obtained at dental implant placement and used for histological analysis. Safety was evaluated by oral examinations, radiographs, serum chemistries, and hematology. Results: A significant amount of new bone was formed by 6 months postoperatively in each group. The mean change in bone height in the rhBMP-2/ACS subjects was 7.83 ± 3.52 mm versus 9.46 ± 4.11 mm for the bone graft subjects. At 6 months after dental restoration, the induced bone in the rhBMP-2/ACS group was significantly denser than that in the bone graft group. No marked differences were found in the histologic parameters evaluated between the 2 groups. The new bone was comparable to the native bone in density and structure in both groups. The success rate for the rhBMP-2/ACS group was 79% (64 of 81 subjects), and 201 of 251 implants placed in the bone graft group and 199 of 241 implants placed in the rhBMP-2/ACS group were integrated, retained, and functional at 6 months after loading. No adverse events were deemed related to the rhBMP-2/ACS treatment. The autograft group was noted to have a 17% rate of long-term parasthesia, pain, or gait disturbance related to the bone graft harvest. Conclusions: The results of our multicenter, randomized, prospective, clinical trial have shown the effectiveness and safety of rhBMP-2/ACS compared with bone graft for sinus floor augmentation. The study's primary endpoint was exceeded, and the implants placed in rhBMP-2/ACS and bone graft groups performed similarly after functional loading.

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