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| Summary of 3 and 6 Month Results
Clinical and radiographic measures demonstrate that GEM 21S® is effective in treating moderate to severe periodontal intraosseous defects. The key benefits of GEM 21S® in its commercially available concentration (0.3 mg/ml PDGF) are highlighted in the series of charts below. |
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| Radiographic Linear Bone Growth for GEM 21S® vs. Control at 6 Months |
Radiographic Percent Bone Fill for GEM 21S® vs. Control at 6 Months |
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| Important Safety Information. View the Package Insert:  United States Canada - English Canada - FrenchTo view a presentation about GEM 21S®, click here. |
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| It is important to note that radiographic measures of bone fill and linear bone growth substantially underestimate the actual bone gain measured directly by clinical re-entry.11,12 In this pivotal trial, which included many private practitioners, only radiographic measures of % bone fill and linear bone growth were allowed. |
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| Representative cases from the GEM 21S® pivotal trial: Case 1 Case 2 Case 3 Case 4 Case 5 |
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| Clinical Attachment Level Gain (CAL) at Baseline and 6 Months |
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| GEM 21S® accelerates CAL gain and significantly improves CAL gain between baseline and six months. (Data excludes single protocol deviation.) |
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GEM 21S® Increases Predictability:
Radiographic Percent Bone Fill Cumulative Distribution |
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| In this chart, the Y axis represents the cumulative proportion of patients treated with either β-TCP alone or β-TCP in combination with PDGF. The X axis represents percent bone fill. In this example, when you look at half of the patients treated during the course of this clinical trial, the GEM 21S® treated patients achieved greater than 49% bone fill, while the β-TCP control group achieved no more than 20% bone fill. The clinical relevance of these distribution curves cannot be overstated, namely that it appears that when treating 1, 2, 3-walled and circumferential defects, one can expect more consistently reliable and quantitatively better results (i.e. greater bone fill) with GEM 21S® than with a purely osteoconductive matrix, i.e. β-TCP, alone. The addition of the protein PDGF appears to make a significant difference in the performance of the graft in the treatment of these defects. |
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