title: Sinus augmentation with bovine hydroxyapatite/synthetic peptide in a sodium hyaluronate carrier (PepGen P-15 Putty): a clinical investigation of different healing times.
abstract: OBJECTIVE
  Augmentation of the sinus floor with autogenous bone often requires an extra donor site, which is associated with a risk of morbidity, and current grafting protocols involve healing times of up to 9 months. In this prospective in vivo study, the time-dependent efficacy of PepGen P-15 Putty, a combination of bovine hydroxyapatite and synthetic peptide in a sodium hyaluronate carrier, was evaluated in sinus grafting.
  
  
  METHODS
  Twenty-four edentulous patients received bilateral sinus augmentations with PepGen P-15 Putty, which mimics the cell-binding domain of type I collagen responsible for cell migration, differentiation, and proliferation. The patients were randomly divided into four groups of six patients each, corresponding to 2, 4, 6, and 9 months of healing postaugmentation. After these time intervals, bone biopsy specimens were retrieved through the alveolar bone crest into the augmented sinus, and subsequently oral implants were placed. The specimens were immersed in buffered formalin, scanned with a desktop microcomputed tomography machine, and processed for histologic and histomorphometric evaluation. A mixed model was used for statistical analysis.
  
  
  RESULTS
  Three-dimensional microcomputed tomography depicted the distinct structure of trabecular bone encompassing remnants of PepGen, and histologic evaluation revealed osteoblasts and osteoid with osteocytes in the vicinity of the PepGen particles at all healing stages. Histomorphometric results indicated an increase in the newly formed bone fraction in the specimens as follows: 21.3% (± 2.33) at 2 months, 21.9% (± 8.9) at 4 months, 28.5% (± 6.9) at 6 months, and 29.8% (± 11.8) at 9 months. The differences were statistically insignificant. All implants placed in the augmented sites integrated and were restored prosthetically.
  
  
  CONCLUSIONS
  PepGen can be used successfully for maxillary sinus augmentation. These data provide evidence that implant placement, even after only 2 months of healing, may be possible.
authors.affiliation: Department of Prosthodontics, School of Dentistry, Albert Ludwigs University, Freiburg, Germany. frank.butz@uniklinik-freiburg.de
authors.forename: Frank
authors.initials: F
authors.lastname: Butz
authors.forename: Maria
authors.initials: M
authors.lastname: Bächle
authors.forename: Markus
authors.initials: M
authors.lastname: Ofer
authors.forename: Katja
authors.initials: K
authors.lastname: Marquardt
authors.forename: Ralf J
authors.initials: RJ
authors.lastname: Kohal
mesh_terms: D016301:Alveolar Bone Loss / Q000000981:diagnostic imaging / Q000628:therapy*; D000818:Animals; D001857:Bone Matrix; D001861:Bone Regeneration / Q000187:drug effects*; D018786:Bone Substitutes / Q000627:therapeutic use*; D002417:Cattle; D003758:Dental Implantation, Endosseous / Q000379:methods; D004337:Drug Carriers; D004338:Drug Combinations; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use; D006882:Hydroxyapatites / Q000627:therapeutic use; D021621:Imaging, Three-Dimensional; D008437:Maxilla / Q000000981:diagnostic imaging; D013516:Oral Surgical Procedures, Preprosthetic / Q000379:methods*; D010012:Osteogenesis / Q000187:drug effects*; D011446:Prospective Studies; D059546:Sinus Floor Augmentation / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D055114:X-Ray Microtomography
chemical_list: D018786:Bone Substitutes; D004337:Drug Carriers; D004338:Drug Combinations; D006882:Hydroxyapatites; C403137:PepGen P-15; D006820:Hyaluronic Acid