4C Practice Growth
The latest evidence on growth factors and how to incorporate GEM 21S® into your practice
The evidenced based conclusions following an extensive assessment of 385 articles of which 153 met the inclusion criteria and were analyzed qualitatively with 150 studies providing data for the network meta-analysis were as follows:
Based on an analysis of the current evidence and expert opinion, the panel concluded that the appropriate use of biologics in periodontal practice is generally safe and provides added benefits to conventional treatment approaches.1
2UNDERSTAND
1REVIEW
The Science Behind Biologics (Page 3)
Overall, rhPDGF-BB exhibited the attachment level gain, pocket depth reduction, less gingival recession and The selection of the type of Bone Graft (autogenous, allogeneic, xenogeneic or synthetic BG) and the type of biologic agent (EMD, PRF, PRP or rhPDGF-BB) plays an important role on the final results, with rhPDGF-BB [or] PRF associated with superior clinical and radiographic outcomes compared to PRP and EMD, and rhPDGF- BB exhibiting the largest effect size for most parameters.²
Objectives:
Superior long-term stability, periodontal health, and esthetics after surgical treatment of infrabony defects have been demonstrated with the use of some biologic agents (i.e., EMD and rhPDGF-BB).¹
3MASTER
The latest peer-reviewed clinical evidence on the efficacy of biologics in contemporary periodontal practice (Page 4)
4LEARN Clinical Case Reports (Page 6–7)
“Techniques for Achieving Optimum Soft Tissue and Bone Healing for Esthetics and Function Around Teeth and Implants” (Page 5)
Overall, our findings revealed that the addition of biologic agents to BG (bone graft) materials significantly enhances the clinical (CAL gain, PD red, REC change) and radiographic (rBF and rLBG) outcomes of periodontal regeneration as compared to BGs alone and flap procedures.²
The goal of the procedure was the lost hard tissue support attachment apparatus, associated to allow for a significantly term prognosis. The evidenced-based usage of GEM 21S® as part protocol has been documented that: hard and soft tissue regeneration intrabony defects.
5COMMUNICATE Tips for navigating patient FAQs (Page 8-9)
6REGISTER Educational Events (Page 10)
7ACCESS Special Offer (Page 11)
Generally accepted to be a mediator of tissue repair, the use of growth factors in periodontology and oral surgery is well documented over several decades of research. As a pioneer in the effort to translate regenerative growth factor research into practical applications, Dr. Samuel Lynch focused on the body’s ability to heal and what factors enabled the body to do so. His breakthrough efforts resulted in the development of the recombinant human platelet-derived growth factor BB (rhPDGF-BB) known commercially as GEM 21S®, for the treatment of certain osseous defects and gingival recession caused by peridontal disease.¹
Dr. Lynch talks about some of his earliest experiences in the lab and what differentiates GEM 21S®.
GEM 21S® delivers
Consistency
as the only off-the-shelf source of purified rhPDGF approved for bone and soft tissue regeneration.1
Cellular Proliferation
once the cells migrate to the site. This cellular activity of mitogenesis stimulates angiogenesis, resulting in more rapid healing and new bone formation.2 This cascade of events is highlighted by…
Cellular Attraction
by signaling and recruiting the specific cells that the body needs to regenerate bone and the surrounding tissues (chemotaxis).2
Clinical Outcomes
as one of the most researched growth factors in dentistry. It has been proven to be safe and effective in regenerating bone and soft tissue in more than 500 publications and 60+ clinical studies.3
The American Academy of Periodontology (AAP) Best Evidence Consensus (BEC)
With the use of biologics progressively becoming a core component of contemporary periodontal practice, the goal of the American Academy of Periodontology (AAP) best evidence consensus (BEC) was to provide a state-of-the-art, evidence-based perspective on the therapeutic application of autologous blood-derived products (ABPs), enamel matrix derivative (EMD), recombinant human platelet-derived growth factor BB (rhPDGF-BB), and recombinant human bone morphogenetic protein 2 (rhBMP-2). The purpose was to address their safety, indications, and effectiveness in specific clinical scenarios.
The evidenced based conclusions following an extensive assessment of 385 articles of which 153 met the inclusion criteria and were analyzed qualitatively with 150 studies providing data for the network meta-analysis were as follows:
Based on an analysis of the current evidence and expert opinion, the panel concluded that the appropriate use of biologics in periodontal practice is generally safe and provides added benefits to conventional treatment approaches.1
The selection of the type of Bone Graft (autogenous, allogeneic, xenogeneic or synthetic BG) and the type of biologic agent (EMD, PRF, PRP or rhPDGF-BB) plays an important role on the final results, with rhPDGF-BB [or] PRF associated with superior clinical and radiographic outcomes compared to PRP and EMD, and rhPDGF-BB exhibiting the largest effect size for most parameters.²
Superior long-term stability, periodontal health, and esthetics after surgical treatment of infrabony defects have been demonstrated with the use of some biologic agents (i.e., EMD and rhPDGF-BB).¹
Overall, rhPDGF-BB exhibited the largest effect size for most parameters, including clinical attachment level gain, pocket depth reduction, less gingival recession and radiographic linear bone gain.²
Overall, our findings revealed that the addition of biologic agents to BG (bone graft) materials significantly enhances the clinical (CAL gain, PD red, REC change) and radiographic (rBF and rLBG) outcomes of periodontal regeneration as compared to BGs alone and flap procedures.²
“Techniques
for Achieving Optimum Soft Tissue and Bone Healing for Esthetics and Function Around Teeth and Implants”
Watch Dr. Michael McGuire’s 1-hour lecture to:
ǐ Uncover evidence-based alternatives using GEM 21S®.
ǐ Discuss outcomes and how it relates to what they do in practice.
ǐ Explain what kind of attachments are they gaining.
ǐ Examine stability in the long term.
C L INICAL CASE REPOR T
C L INICAL CASE REPOR T
LONG TERM FOLLOW UP OF A PERIODONTAL
DEFECT IN THE POSTERIOR MANDIBLE
A 65 year old female patient presented with clinical and radiographic evidence of an osseous defect distal of #19. At baseline, the pocket depth was approximately 10 mm.
LONG TERM FOLLOW UP OF A PERIODONTAL DEFECT IN THE POSTERIOR MANDIBLE
The crown was biologically shaped and the root detoxified using Ellman burs. After flap opening and complete defect debridement, GEM 21S® was used to fill the defect.
The graft was then covered with Geistlich Bio-Gide®.
A 65 year old female patient presented with clinical and radiographic evidence of an osseous defect distal of #19. At baseline, the pocket depth was approximately 10 mm
Objectives:
The crown was biologically shaped and the root detoxified using Ellman burs. After flap opening and complete defect debridement, GEM 21S® was used to fill the defect.
The graft was then covered with Geistlich Bio-Gide®.
Base line
GEM
Objectives:
The goal of the procedure was to restore the lost hard tissue support ie. periodontal attachment apparatus, associated with #19 to allow for a significantly improved longterm prognosis. The evidenced-based usage of GEM 21S® as part of our surgical protocol has been documented to do just that: hard and soft tissue regeneration in intrabony defects.
Conclusions:
The goal of the procedure was to restore the lost hard tissue support ie. periodontal attachment apparatus, associated with #19 to allow for a significantly improved longterm prognosis. The evidenced-based usage of GEM 21S® as part of our surgical protocol has been documented to do just that: hard and soft tissue regeneration in intrabony defects.
10-year follow-up radiographs showed evidence of bone fill. Clinically, maturation of interdental tissue is evident as well.
Conclusions:
The 10-year follow up clinical photos are demonstrating stability of bone, lack of facial and minimal interproximal recession. Stability of the bone radiographically is evident as well.
10-year follow-up radiographs showed evidence of bone fill. Clinically, maturation of interdental tissue is evident as well.
The 10-year follow up clinical photos are demonstrating stability of bone, lack of facial and minimal interproximal recession. Stability of the bone radiographically is evident as well.
21S® did not only enhance the outcome of this challenging case, but ensured its stability over a 10 year follow-up.”
– Dr. Robert Levine
Dr. Robert Levine Philadelphia, PA
Dr. Robert Levine Philadelphia, PA
Objectives:
C a s e S ummary
C a s e S ummary
The evidenced-based usage of GEM 21S® as part of our surgical protocol helped the restoration of both hard and soft tissue healing and supported improving the long-term prognosis in this case at the 10-year mark. Excellent compliance to supportive periodontal therapy and plaque control by our patient ensured these lasting results held up
The evidenced-based usage of GEM 21S® as part of our surgical protocol helped the restoration of both hard and supported improving the long-term prognosis in this case at the 10-year mark. Excellent compliance to supportive periodontal therapy and plaque control by our patient ensured these
The goal of the procedure was to restore the lost hard tissue support ie. periodontal attachment apparatus, associated with #19 to allow for a significantly improved longterm prognosis. The evidenced-based usage of GEM 21S® as part of our surgical protocol has been documented to do just that: hard and soft tissue regeneration in intrabony defects.
Conclusions:
1 Flap reflection showing the defect on the distal of tooth #19 with a ≥ 10 mm pocket depth.
dimensions of the
shown from the occlusal view
10-year follow-up radiographs showed evidence of bone fill. Clinically, maturation of interdental tissue is evident as well. The 10-year follow up clinical photos are demonstrating stability of bone, lack of facial and minimal interproximal recession. Stability of the bone radiographically is evident as well.
3 Clinical situation 10 years after the surgical procedure.
GEM 21S® did not only enhance the outcome of this challenging case, but ensured its stability over a 10 year follow-up.”
– Dr. Robert Levine
For
more information on contraindications,
4 Radiograph at 10 years post-op, showing evidence of
4 Radiograph at 10 years post-op, showing evidence of bone fill.
patient only.
The
defect
Flap reflection showing the defect f tooth #19 with a
The dimensions of the defect shown from the occlusal view
3 Clinical situation 10 years after the surgical procedure.
bone fill.
Conversation with a Patient
What is it?
GEM 21S® Growth-Factor Enhanced Matrix is a synthetic bone graft composed of pure, sterile bioengineered platelet-derived growth factor (PDGF) and a bone graft. PDGF is naturally found in our bodies (present in the platelets in your blood) and is often referred to as nature’s wound healing protein. Whenever you experience a wound or surgery, your blood clots and platelets release PDGF (along with other proteins), stimulating the healing process. Unfortunately, as we grow older and with certain conditions, the amount of naturally occurring PDGF declines so we no longer heal as we did previously. GEM 21S® replenishes the amount of PDGF at the grafted site to aid in faster, better healing.
How does GEM 21S® promote healing?
Since GEM 21S® will be implanted under your gums, you won’t be able to see the powerful effects of the treatment as it occurs. The illustrations that follow describe how GEM 21S® speeds up your body’s natural healing process. (Fig. 1)
Your doctor will begin by thoroughly cleaning the area to be treated. Once properly prepared, GEM 21S® is used to fill the area where bone and other supporting structures have been lost. GEM 21S® acts by signaling your body to actively begin to heal and regenerate healthy bone and soft tissues. (Fig. 2)
GEM 21S® attracts the specific cells that your body needs to regenerate bone and the surrounding tissues, causing them to multiply in number. This increase in cellular activity results in a more rapid healing process.* (Fig. 3)
GEM 21S® is gradually replaced with your own bone and other normal tissues. Several months after treatment with GEM 21S®, healing is complete. (Fig. 4)
Is it Safe?
YES. GEM 21S® has been fully approved by FDA. In addition to being the only FDA-approved product available for use in dental surgery that contains pure PDGF (nature’s wound healing protein), GEM 21S® is also one of the most rigorously studied products in dentistry over the last 20 years.
How long will it take to see results?
Your gums will typically heal within 1 -2 weeks. While GEM 21S® promotes rapid healing, it takes bone several months to mature into its final dense structure. The goal of treatment with GEM 21S® is restoration of a normal healthy condition (complete regeneration of the bone and soft tissues).
How will I benefit?
GEM 21S® will improve the health of the jaw bone and surrounding tissues that have been damaged as a result of periodontal disease. GEM 21S® is the only product available for use in dental surgery that contains pure PDGF to improve healing.
FIGURE 4
FIGURE 3
FIGURE 2
FIGURE 1
JOIN US: Latest Advances in the Use of Biologics in Oral Tissue Regeneration
Learn from dynamic regenerative experts introducing innovative solutions for your practice:
ǐ Examine the latest advances in the use of biologics in oral tissue regeneration
ǐ Attendees will be provided an opportunity to interact directly with the authors of the American Academy of Periodontology – Best Evidence Consensus on Biologics
ǐ Review the latest evidence on the efficacy of biologics in contemporary periodontal practice
ǐ Discuss the impact on long term outcomes
ǐ Formulate evidence-based recommendations for clinical practice
ǐ Explore clinical case experiences, techniques and treatment solutions
Disclaimers:
• This program is designed for non-resident periodontists and oral surgeons.
• This complimentary educational event is sponsored by Geistlich Pharma North America, Inc.
• Cocktails and an array of hors d’oeuvres will be served as the evening goes on.
• Space is limited! Be sure to reserve your spot!
May 11th, 2023
May 25th, 2023
June 1st, 2023
GEM 21S® SPECIAL OFFER:
Stock Up on Innovation You Can Count on
Thank you for exploring GEM 21S® outcomes. Ready to bring GEM 21S® into your regenerative regimen? Now through June 15th, you can stock up and save on GEM 21S®.
Buy 4 @ $225 each (Total $900) 18% DISCOUNT Code: Shine4
TERMS: Valid March 16–June 15, 2023. Limit one redemption per week per customer. Offer subject to change. This offer cannot be combined with any other offers/discounts. Sales promotions not applicable in Puerto Rico and exclude Dental Service Organizations, Government, Military and University Accounts.
Buy 22 @ $199 each get 2 free (Total $4,378) 33% DISCOUNT Code: Shine24
Important Prescribing Information
CONTRAINDICATIONS
As with any periodontal procedure where bone grafting material is used, GEM 21S® is CONTRAINDICATED in the presence of one or more of the following clinical situations: untreated acute infections at the surgical site; untreated malignant neoplasm(s) at the surgical site; patients with a known hypersensitivity to any product component (ß-TCP or rhPDGF-BB); intraoperative soft tissue coverage is required for a given surgical procedure but such coverage is not possible; or conditions in which general bone grafting is not advisable.
WARNINGS
The safety and effectiveness of GEM 21S® has not been established: In patients with an active malignant neoplasm and should therefore not be used in such patients; in other non-periodontal bony locations, including other tissues of the oral and craniofacial region such as bone graft sites, tooth extraction sites, bone cavities after cystectomy, and bone defects resulting from traumatic or pathological origin. GEM 21S® has also not been studied in situations where it would be AUGMENTing autogenous bone and other bone grafting materials; in pregnant and nursing women. It is not known whether rhPDGF-BB is excreted in the milk of nursing women; in pediatric patients below the age of 18 years; in patients with teeth exhibiting mobility of greater than Grade II or a Class III furcation; in patients with frequent or excessive use of tobacco products. Careful consideration should be given to alternative therapies prior to performing bone grafting in patients: who have severe endocrine-induced bone diseases (e.g. hyperparathyroidism); who are receiving immunosuppressive therapy; or who have known conditions that may lead to bleeding complications (e.g. hemophilia).
The GEM 21S® grafting material is intended to be placed into periodontally related defects. It must not be injected systemically.
The radiopacity of GEM 21S® is comparable to that of bone and diminishes as GEM 21S® is resorbed. The radiopacity of GEM 21S® must be considered when evaluating radiographs as it may mask underlying pathological conditions.
Geistlich Pharma North America, Inc.
400 Alexander Park Drive
Suite 302
Princeton, NJ 08540 USA
855-799-5500
geistlich.us
PRECAUTIONS
GEM 21S® contains becaplermin – a recombinantly produced, human platelet-derived growth factor, homodimer BB (rhPDGF-BB), which is a protein that has been shown to promote the formation of bone in periodontal defects. rhPDGF-BB (“PDGF”) is also the active ingredient of another FDA approved product, REGRANEX® Gel, which is a topical gel formulation, indicated for the treatment of lower extremity diabetic neuropathic ulcers.¹
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 rhPDGF-BB in periodontal defects and malignancy or mortality secondary to malignancy.
ADVERSE EVENTS
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.
INDICATIONS (US):
GEM 21S® is indicated to treat the following periodontally related defects:
•lntrabony periodontal defects;
•Furcation periodontal defects; and
•Gingival recession associated with periodontal defects.
1. GEM 21S® Packet Insert
Lynch Biologics, LLC
393 Nichol Mill Lane Suite 280
Franklin, TN 37067 USA
800-874-2334
lynchbiologics.com