GEM 21S® has been evaluated in the most extensive, prospective, randomized, controlled, blinded clinical trial conducted for a regenerative product in dentistry. This trial was designed to evaluate both the safety and efficacy of this new product. It was intended to satisfy FDA requirements as well as to address the unique aspects of translating a novel technology from the research and development phase to patient care in clinical practice.
The trial was a large, mulitcenter study involving 180 patients and 11 clinical sites (4 universities and 7 private practices). This diversity allows the trial results to be applicable to multiple practice conditions and more clinically relevant than a homogenous study involving only university based clinicians or private practitioners.
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Study Design
Three treatment groups were included in the trial:
Group I: β-TCP + 0.3 mg/ml rhPDGF-BB + buffer solution (GEM 21S®)
Group II: β-TCP + 1.0 mg/ml rhPDGF-BB + buffer solution
Group III: β-TCP + buffer solution alone (Active Control)
Clinical and radiographic endpoints were assessed in all patients at 3 and 6 months.
Patient Selection
All patients involved in the pivotal trial required surgical intervention to treat significant intraosseous periodontal defects. Patients were selected for the trial based on specific inclusion and exclusion criteria generally considered prudent in the design of regenerative studies.
Case 1 Case 2 Case 3 Case 4 Case 5Inclusion Criteria
Exclusion Criteria
Pregnant wome or women intending to become pregnantduring study
History of oral cancer or HIV Signs of acute infection Class III furcation defects Surgery on the study tooth in the last year Age 25 - 75 years Grade I and II furcations allowable Smokers up to 1 pack per day Pocket depth ≥ 7 mm Bone defect ≥ 4 mm (1-3 bone wallsand circumferential
Clinical Endpoints
Outcomes were based on clinical and radiographic endpoints measured at 3 and 6 months, with change from baseline results for the rhPDGF-BB treated groups (Group I or II) compared to change from baseline results for the active control (Group III). All critical outcome measures typically included in regenerative studies were evaluated.
Outcome Measures
Clinical Attachment Level (CAL) Linear Bone Growth (LBG) % Bone Fill (%BF) Composite Outcome (clinical + radiographic) Pocket Depth Reduction (PDR) Gingival Recession (GR) Wound Healing (WH) Comparison to Current TherapiesDemographics
A diverse group of adult patients, representative of patients seen in everyday clincial practice, in terms of age, smoking status, gender, and ethnicity were included in the pivotal trial.
Patient Demographics
Baseline Defects
There were no statistically significant differences among treatment groups in terms of baseline defect characteristics. It is there therefore possible to conclude that any differences in clinical outcomes are directly attributable to the specific treatment used (β-TCP with or without the active molecule rhPDGF-BB) and not to differences in baseline defects.
Baseline Defect Characteristics
Safety Outcomes
The pivotal trial reinforced PDGF's established safety profile of more than eight years clinical
use as a wound healing agent. In this study, no serious adverse events were associated
with the use of GEM 21S®.