|GEM 21S® Contains a Powerful Growth Factor|
GEM 21S® Growth-factor Enhanced Matrix promotes regeneration of bone, cementum and periodontal ligament like no other therapy available.
Nature’s wound healing agent
GEM 21S® is the only dental therapy containing PDGF, one of the main growth factors found in the human body often referred to as “nature’s wound healing agent,” and well known for its role in wound healing. PDGF exerts its effects through the recruitment and stimulation of cells within the surrounding matrix.
An adequate blood supply is critical to the success of any grafting procedure. Extensive in-vitro and in-vivo studies have demonstrated that PDGF-BB is a powerful stimulant of angiogenesis that also stabilizes newly formed blood vessels.
More Potent than PRP or PRGF
GEM 21S® contains at least 1,000 times more active growth factor than either PRP or PRGF preparations.6,7,8,9
More potent than Enamel Matrix Derivative
In defects with similar baseline characteristics, GEM 21S® provides more radiographic bone fill and linear bone gain, greater gains in clinical attachment level, and faster healing.2,3,4
GEM 21S® Increases Predictability
Clinical and radiographic measures demonstrate that GEM 21S® is effective in treating moderate to severe periodontal intraosseous defects.
Improved outcomes among smokers
Chronic smoking can significantly compromise periodontal treatment outcomes.* Despite smoking up to 1 pack per day, patients treated with GEM 21S® realized significantly better clinical outcomes than those treated with graft material alone.
Patients from the GEM 21S® pivotal clinical trial continued to be monitored by their treating physicians for a total of 36 months. The data collected demonstrates the continued long-term efficacy of GEM 21S® treatment.
- The GEM 21S® group demonstrated a statistically greater amount of bone fill over the control throughout 24 months.
- β-TCP group failed to reach the level of bone fill or soft tissue gains that was achieved by the GEM 21S® group.
GEM 21S® is a predictable treatment for moderate to severe periodontal defects allowing you the ability to retain patients’ natural teeth with confidence.
Radiographic Percent Bone Fill
6 to 36 months
Radiographic Linear Bone Growth
6 to 36 months
Clinical Attachment Level Gain
6 to 36 months
IMPORTANT SAFETY INFORMATION
GEM 21S® Growth-factor Enhanced Matrix is intended for use by clinicians familiar with periodontal surgical grafting techniques. It should not be used in the presence of untreated acute infections or untreated malignant neoplasm(s) at the surgical site, where intra-operative soft tissue coverage is not possible, where bone grafting is not advisable or in patients with a known hypersensitivity to one of its components. It must not be injected systemically.
The safety and effectiveness of GEM 21S® has not been established in patients with an active malignant neoplasm, other non-periodontal bony locations, in patients less than 18 years old, in pregnant or nursing women, in patients with frequent/excessive tobacco use (e.g. smoking more than one pack per day) and in patients with Class III furcations or with teeth exhibiting mobility greater than Grade II. In a 180 patient clinical trial, there were no serious adverse events related to GEM 21S®.
An increased rate of mortality secondary to malignancy with use of high quantities (i.e. 3 or more tubes of REGRANEX® Gel) was demonstrated in a single study of its use in treatment of diabetic, neuropathic ulcers. Two subsequent studies did not demonstrate this increased rate. No relationship has been demonstrated regarding use of PDGF in periodontal defects and malignancy or mortality secondary to malignancy.
Although no serious adverse reactions attributable to GEM 21S® were reported in a 180 patient clinical trial, patients being treated with GEM 21S® may experience any of the following adverse events that have been reported in the literature with regard to periodontal surgical grafting procedures: swelling; pain; bleeding; hematoma; dizziness; fainting; difficulty breathing, eating, or speaking; sinusitis; headaches; increased tooth mobility; superficial or deep wound infection; cellulitis; wound dehiscence; neuralgia and loss of sensation locally and peripherally; and, anaphylaxis. Occurrence of one or more of these conditions may require an additional surgical procedure and may also require removal of the grafting material.
View the package insert: U.S. Package Insert | Canadian Package Insert - English
Canadian Package Insert - French
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2 Mariotti M, Maier J. Angiogenesis: An Overview. New Frontiers in Angiogenesis. 2006 Forough R. Ed. Netherlands: Springer Verlag; 1-29.
3 Hirschi KK, Rohovsky SA, et al. Endothelial cells modulate the proliferation of mural cell precursors via platelet-derived growth factor-BB and heterotypic cell contact. Circ. Res. 1999, 84:298-305.
4 Lindahl P, Johansson BR, et al. Pericyte loss and microaneurysm formation in PDGF-B-deficient mice. Science. 1997, 277:242-245
5 Bowen-Pope DF, Malpass TW, Foster DM, Ross R. Platelet-derived growth factor in vivo: Levels, activity, and rate of clearance. Blood 1984; 64:458-469.
6 Huang JS, Huang SS, Deuel TF. Human platelet-derived growth-factor; Radioimmunoassay and discovery of a specific plasma-binding protein. J Cell Biol 1983; 97:383-388.
7 Singh PJK, Chailkin MA, Stiles CD. Phylogenetic analysis of platelet-derived growth factor by radio-receptor assay. J Cell Biol 1982; 95: 667-671
9 Nevins m, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet Derived Growth Factor (rhPDGF-BB) Stimulates Bone Fill and Rate of Attachment Level Gain. Results of a Large, Multicenter Randomized Controlled Trial. J Periodontol, 2005; 76: 2205-2215.
10 Heijl L, Heden G, Svardstrom G, Ostgren A. Enamel matrix derivative (EMDOGAIN) in the treatment of intrabony periodontal defects. J Clin Periodontol. 1997; 24: 705-714.
11 Zetterstrom O, Andersson C, Driksson L, et al. Clinical safety of enamel matrix derivative (EMDOGAIN) in the treatment of periodontal defects. J Clin Periodontol. 1997; 24: 697-704.