Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.
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 (> or =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 < or =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.


CONCLUSIONS
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.
Fiorellini
Joseph P
JP
Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA 02115, USA. joseph_fiorellini@hsdm.harvard.edu
Howell
T Howard
TH
Cochran
David
D
Malmquist
Jay
J
Lilly
Leslie C
LC
Spagnoli
Daniel
D
Toljanic
Joseph
J
Jones
Archie
A
Nevins
Myron
M
D020341:Absorbable Implants; D016301:Alveolar Bone Loss / Q000209:etiology / Q000601:surgery*; D000540:Alveolar Ridge Augmentation / Q000379:methods; D000704:Analysis of Variance; D015519:Bone Density; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000008:administration & dosage / Q000494:pharmacology*; D001861:Bone Regeneration / Q000187:drug effects*; D003094:Collagen; D004311:Double-Blind Method; D004337:Drug Carriers; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013516:Oral Surgical Procedures, Preprosthetic / Q000009:adverse effects / Q000379:methods*; D011994:Recombinant Proteins; D018709:Statistics, Nonparametric; D014081:Tooth Extraction / Q000009:adverse effects; D020390:Tooth Socket / Q000601:surgery*; D016212:Transforming Growth Factor beta / Q000008:administration & dosage / Q000494:pharmacology*
C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D004337:Drug Carriers; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2; D003094:Collagen