TY - JOUR
T1 - Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation
AU - Fiorellini, Joseph P.
AU - Howard Howell, T.
AU - Cochran, David
AU - Malmquist, Jay
AU - Lilly, Leslie C.
AU - Spagnoli, Daniel
AU - Toljanic, Joseph
AU - Jones, Archie
AU - Nevins, Myron
PY - 2005/4
Y1 - 2005/4
N2 - Background: Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction. Methods: Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (≥50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation. Results: Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P≤0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone. Conclusion: The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants.
AB - Background: Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction. Methods: Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (≥50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation. Results: Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P≤0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone. Conclusion: The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants.
KW - Alveolar bone loss/surgery
KW - Alveolar ridge augmentation
KW - Bone morphogenetic protein-2, recombinant human
KW - Bone regeneration
KW - Clinical studies, prospective
KW - Clinical trials
KW - Clinical trials, randomized
KW - Collagen/therapeutic use
KW - Controlled
KW - Multicenter studies
KW - Proteins, bone morphogenetic
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U2 - 10.1902/jop.2005.76.4.605
DO - 10.1902/jop.2005.76.4.605
M3 - Article
C2 - 15857102
AN - SCOPUS:19044369324
SN - 0022-3492
VL - 76
SP - 605
EP - 613
JO - Journal of periodontology
JF - Journal of periodontology
IS - 4
ER -