title: Increase of homogenous new bone formation using osteoinductive factor rhGDF-5 during sinus floor augmentation in Goettingen Minipigs.
abstract: OBJECTIVE
  The aim of this study was to test the hypothesis that recombinant human growth and differentiation factor-5 (rhGDF-5) induces an increased and homogenous distribution of new bone formation across the entire volume of sinus floor augmentation in 12 Goettingen Minipigs.
  
  
  METHODS
  In a randomized split-mouth design, one maxillary sinus was augmented with the bone substitute β-TCP, whereas a combination of β-TCP and the osteoinductive growth factor rhGDF-5 was used on the contralateral side. To evaluate the influence of dose and time on the effectiveness of the factor, two different concentrations of rhGDF-5 (400 μg and 800 μg) and healing periods (4 and 12 weeks) were each analysed.
  
  
  RESULTS
  After 4 weeks, a homogenous gradient of bone formation could be observed for all dosage groups, with decreasing bone density from the local bone towards the sinus membrane. Both test groups, however, achieved a higher total level of bone formation compared with the control group, which was only significant in the low-dose group (P = 0.0184). After 12 weeks, the influence of the growth factor significantly depends on the region (P = 0.023). In the low-dose group, the new bone formation did not differ significantly within the examined regions of the graft (P = 0.1118), suggesting a homogeneous bone formation over the entire augmentation. The gradient of the high-dose group was similar to the control group with a decrease of local bone development.
  
  
  CONCLUSIONS
  rhGDF-5 delivered on a β-TCP scaffold material leads to an increase in homogeneous new bone formation across the entire volume of the sinus floor augmentation.
authors.affiliation: Department of Oral and Maxillofacial Surgery, University of Goettingen, Goettingen, Germany.
authors.forename: Phillipp
authors.identifier: http://orcid.org/0000-0003-3694-2828
authors.initials: P
authors.lastname: Brockmeyer
authors.affiliation: Department of Medical Statistics, University of Goettingen, Goettingen, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Lange
authors.affiliation: Private practise, Goettingen, Germany.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Hahn
authors.affiliation: Department of Oral and Maxillofacial Surgery, University of Goettingen, Goettingen, Germany.
authors.forename: Henning
authors.initials: H
authors.lastname: Schliephake
authors.affiliation: Department of Oral and Maxillofacial Surgery, University of Goettingen, Goettingen, Germany.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Matthias Gruber
mesh_terms: D000818:Animals; D001861:Bone Regeneration / Q000187:drug effects*; D018786:Bone Substitutes; D005260:Female; D055428:Growth Differentiation Factor 5 / Q000494:pharmacology*; D023421:Models, Animal; D010012:Osteogenesis / Q000187:drug effects*; D059546:Sinus Floor Augmentation / Q000379:methods; D013552:Swine; D013556:Swine, Miniature; D013997:Time Factors; D014945:Wound Healing
chemical_list: D018786:Bone Substitutes; D055428:Growth Differentiation Factor 5
keywords: GDF-5; Goettingen Minipig; bone regeneration; osteoconduction; osteoinduction; rhGDF-5; sinus floor augmentation