title: De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation.
abstract: OBJECTIVE
  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.
  
  
  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 <or= .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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Oral and Maxillofacial Surgery Service, Loma Linda University Medical Center, Loma Linda, CA, USA.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Boyne
authors.forename: Leslie C
authors.initials: LC
authors.lastname: Lilly
authors.forename: Robert E
authors.initials: RE
authors.lastname: Marx
authors.forename: Peter K
authors.initials: PK
authors.lastname: Moy
authors.forename: Myron
authors.initials: M
authors.lastname: Nevins
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Spagnoli
authors.forename: R Gilbert
authors.initials: RG
authors.lastname: Triplett
mesh_terms: D000539:Alveolar Process / Q000033:anatomy & histology / Q000000981:diagnostic imaging; D000704:Analysis of Variance; D015519:Bone Density; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000008:administration & dosage*; D016025:Bone Transplantation; D003758:Dental Implantation, Endosseous; D015921:Dental Implants; D019094:Dental Prosthesis, Implant-Supported; D019232:Dental Restoration Failure; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008443:Maxillary Sinus / Q000601:surgery*; D008875:Middle Aged; D013516:Oral Surgical Procedures, Preprosthetic; D016348:Osseointegration; D010012:Osteogenesis / Q000187:drug effects*; D011994:Recombinant Proteins / Q000008:administration & dosage; D018709:Statistics, Nonparametric; D014057:Tomography, X-Ray Computed; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*
chemical_list: C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D015921:Dental Implants; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta