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Platelet‐Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36‐Month Extension Results From a Randomized, Controlled, Double‐Masked Clinical Trial
Author(s) -
Nevins Myron,
Kao Richard T.,
McGuire Michael K.,
McClain Pamela K.,
Hinrichs James E.,
McAllister Bradley S.,
Reddy Michael S.,
Nevins Marc L.,
Genco Robert J.,
Lynch Samuel E.,
Giannobile William V.
Publication year - 2013
Publication title -
journal of periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.036
H-Index - 156
eISSN - 1943-3670
pISSN - 0022-3492
DOI - 10.1902/jop.2012.120141
Subject(s) - medicine , randomized controlled trial , dentistry , platelet rich plasma , clinical trial , clinical attachment loss , growth factor , surgery , platelet , periodontal disease , receptor
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. Conclusion: 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).