title: Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial.
abstract: BACKGROUND
  Recombinant human platelet-derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short-term studies up to 6 months in duration. We now provide results from a 36-month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long-term stability of PDGF-BB treatment in patients with localized severe periodontal osseous defects.
  
  
  METHODS
  A total of 135 participants were enrolled from six clinical centers for an extension trial. Eighty-three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β-tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF-BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7 mm and linear bone growth (LBG) ≥1.1 mm.
  
  
  RESULTS
  The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF-BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response.
  
  
  CONCLUSIONS
  PDGF-BB in a synthetic scaffold matrix promotes long-term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects ( ClinicalTrials.gov no. CT01530126).
authors.affiliation: Division of Periodontology, Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, MA, USA. nevinsperimp@aol.com
authors.forename: Myron
authors.initials: M
authors.lastname: Nevins
authors.forename: Richard T
authors.initials: RT
authors.lastname: Kao
authors.forename: Michael K
authors.initials: MK
authors.lastname: McGuire
authors.forename: Pamela K
authors.initials: PK
authors.lastname: McClain
authors.forename: James E
authors.initials: JE
authors.lastname: Hinrichs
authors.forename: Bradley S
authors.initials: BS
authors.lastname: McAllister
authors.forename: Michael S
authors.initials: MS
authors.lastname: Reddy
authors.forename: Marc L
authors.initials: ML
authors.lastname: Nevins
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Genco
authors.forename: Samuel E
authors.initials: SE
authors.lastname: Lynch
authors.forename: William V
authors.initials: WV
authors.lastname: Giannobile
mesh_terms: D016301:Alveolar Bone Loss / Q000000981:diagnostic imaging / Q000188:drug therapy*; D000704:Analysis of Variance; D000077214:Becaplermin; D001861:Bone Regeneration / Q000187:drug effects*; D002130:Calcium Phosphates; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005889:Gingival Recession / Q000188:drug therapy; D006801:Humans; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D020574:Proto-Oncogene Proteins c-sis / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D011859:Radiography; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D055502:Secondary Prevention; D012907:Smoking; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D002130:Calcium Phosphates; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin; C018392:tricalcium phosphate