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Feasibility Study Effectiveness Data
Historical review of scientific literature documents the potential role of PDGF in human bone and periodontal regeneration. Two recent prospecitve human feasibility studies examining safety and effectiveness of rhPDGF-BB when placed on an allograft matrix for the treatment of vertical intrabony and Class II furcation defects suggest a possible positive role for PDGF in periodontal regenerative procedures.7,8 In both studies, improvements in clinical and radiographic parameters were seen. Additionally, following en bloc resection, histologic examination documented substantial periodontal regeneration in both vertical intrabony and Class II furcation defects. Prior to these feasibility studies, documentation of complete regeneration of cementum, periodontal ligament and supporting alveolar bone in human Class II furcation defects had not been seen.
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Important Safety Information.
View the Package Insert:
 United States
 Canada - English
 Canada - French
To view a presentation about GEM 21S®, click here.
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Representative results obtained from sites treated with allograft + rhPDGF-BB in a human clinical trial.*
Case by:
Dr. Myron Nevins
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Case 1 |
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Intraoperative photograph with probe in place showing a 5 mm, primarily horizontal, furcal bone defect on the lingual of tooth #19 |
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*GEM 21S® is not FDA approved for use with allograft
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Low power magnification of class II furcation defect showing complete periodontal regeneration following treatment. |
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High power magnifications of box regions observed in low power photomicrograph, showing complete regeneration of bone, PDL and cementum to the fornix of the furcation. The tooth roots are continuously lined by new cementum. Many blood vessels are present within the new periodontal ligament, suggesting enhanced angiogenesis. |
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Although PDGF appeared to play a positive role in promoting periodontal regeneration when placed on an allograft matrix, it is unknown whether similar results will occur with other bone replacement grafts, i.e. β-TCP. |
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Histology images featured in Case 1 are copyrighted and reproduced with permission from Quintessence Publshing, Inc.
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