Growth Factors vs EMD for Periodontal Defects

Overseen By Arsalan Danesh, D.D.S

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nova Southeastern University

Must not be taking: Phenytoin, Alendronate

Disqualifiers: Pregnancy, Heavy smoking, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for periodontal (gum) disease, focusing on healing bone defects around teeth. One group will receive recombinant human platelet-derived growth factor (GEM-21), while the other will receive enamel matrix derivatives (EMD). The study aims to determine which treatment more effectively regenerates bone. It suits individuals who have had recent dental cleaning but still experience deep gum pockets with bone loss. Participants must be available for follow-up visits over six months. As a Phase 1, Phase 2 trial, this research examines how the treatments work in people and measures their effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've been on medications affecting periodontal status in the past 6 months, like Phenytoin or Alendronate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that recombinant human platelet-derived growth factor (rhPDGF), such as GEM-21, is safe for treating bone problems in the gums. Studies have found it effectively heals these issues without causing major side effects. For instance, one study reported that rhPDGF was safe and effective over six months, with patients experiencing good healing.

Similarly, enamel matrix derivatives (EMD) have been used for many years and are known to be safe. EMD, a natural protein, helps bone regrow and is commonly used to heal bone issues in the mouth.

Both treatments have been well-received in past studies, with serious side effects being rare. Participants in clinical trials can expect these treatments to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for periodontal defects, which often include scaling, root planing, and surgical options, recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft offers a novel approach by actively recruiting stem cells. This treatment encourages cell differentiation and proliferation, which can enhance tissue regeneration. When paired with a bone allograft, it stimulates angiogenesis, or the formation of new blood vessels, which is crucial for effective healing and regeneration. Researchers are excited because this mechanism could potentially improve regeneration outcomes more significantly than current methods.

What evidence suggests that this trial's treatments could be effective for periodontal defects?

This trial will compare two treatments for periodontal defects. Research has shown that one treatment, GEM-21, which participants in this trial may receive, effectively addresses gum and bone problems in the mouth. Studies have found it safe and beneficial for promoting new bone growth by encouraging cell growth and forming new blood vessels. Patients using this treatment have experienced improvements in bone issues and gum health.

Another treatment option in this trial is enamel matrix derivatives (EMD), which has also effectively repaired gum and bone tissues. Clinical results indicate that EMD helps resolve bone problems, especially when combined with bone grafts. Long-term improvements in gum and bone health have been noted with this treatment. Both treatments have demonstrated positive results in managing gum and bone issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Theofilos Koutouzis, DDS, MS

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had scaling and root planing for periodontal disease, with deep pockets next to bone defects in their teeth. They must be able to come back for a 6-month check-up and not have serious health issues or habits like heavy smoking that could affect the results.

Inclusion Criteria

I do not have any major health issues.

I have single or multiple rooted teeth in my upper or lower jaw.

I have bone defects that are not enclosed.

Exclusion Criteria

I have a root tip infection in the area being tested.

Heavy smokers (>10 cigarettes a day)

I am willing to follow the study's rules and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either rh-PDGF or EMD in combination with bone allograft for the treatment of intra-bony defects

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enamel matrix derivatives (EMD)
• Recombinant human platelet derived growth factor (GEM-21)

Trial Overview The study compares two treatments on people with gum disease: one group gets human growth factor (Rh-PDGF) added to a bone graft, while the other gets enamel matrix derivatives (EMD) with a bone graft. Both groups follow the same surgery steps and are checked after six months.

How Is the Trial Designed?

Group I: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft Experimental Treatment 1 Intervention

recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.

Group II: Enamel matrix derivatives (EMD) in combination with bone allograft. Active Control 1 Intervention

Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects.

Recombinant human platelet derived growth factor (GEM-21) is already approved in United States, European Union for the following indications:

Approved in United States as GEM-21 for:

• Periodontal intra-bony defects

Approved in European Union as GEM-21 for:

• Periodontal intra-bony defects

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Published Research Related to This Trial

In a study involving 451 children with growth hormone deficiency, the weekly pegylated human growth hormone (Jintrolong) showed significantly greater increases in height velocity compared to daily rhGH after 25 weeks of treatment.

Both treatments had comparable safety profiles and compliance rates, indicating that Jintrolong is an effective and safe alternative to daily rhGH for managing growth hormone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Luo, X., Hou, L., Liang, L., et al.[2019]

The study involved 9 adult patients with advanced periodontitis and demonstrated that using purified recombinant human platelet-derived growth factor BB (rhPDGF-BB) mixed with bone allograft led to significant periodontal regeneration, including new bone, periodontal ligament, and cementum in both interproximal intrabony defects and Class II furcation lesions.

There were no safety concerns during the study, and the treatment resulted in substantial clinical improvements, with an average clinical attachment level gain of 6.17 mm and a vertical probing depth reduction of 6.42 mm in interproximal defects, indicating effective wound healing and regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. Nevins, M., Camelo, M., Nevins, ML., et al.[2022]

In a study of 79 sites comparing the effects of enamel matrix derivative (EMD) and recombinant human fibroblast growth factor 2 (rhFGF-2) on early wound healing after periodontal surgery, rhFGF-2 showed significantly better outcomes in terms of redness and dehiscence scores.

The findings suggest that rhFGF-2 may enhance early wound healing more effectively than EMD, particularly in patients aged 50 and older and those with non-contained bone defects, although early healing did not predict radiographic bone fill after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of early wound healing using modified papilla preservation technique between enamel matrix derivative and recombinant human fibroblast growth factor. Nakayama, Y., Tabe, S., Igarashi, K., et al.[2023]

Recombinant DNA-derived human growth hormone (rhGH) has been effective in treating various growth disorders, achieving a final height increase of 5-7 cm in conditions like Turner syndrome and Prader-Willi syndrome, although this is less than the gains seen in growth hormone deficiency (GHD).

While rhGH has a good safety record, there are concerns about potential long-term risks of certain cancers, necessitating ongoing monitoring through national cancer registries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of growth hormone in children. Hindmarsh, PC., Dattani, MT.[2006]

In a 2-year study involving 148 adult patients with growth hormone deficiency, recombinant human growth hormone (rhGH) therapy significantly improved body composition, increasing lean body mass and total body water while reducing body fat and waist circumference, especially in the first year.

Despite the benefits, about one-third of patients experienced fluid-related side effects, suggesting that starting with lower doses of rhGH and adjusting them gradually may enhance safety and efficacy, as individual responses varied widely and could not be predicted by baseline characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two years of replacement therapy in adults with growth hormone deficiency. Verhelst, J., Abs, R., Vandeweghe, M., et al.[2019]

In a 36-month study involving 135 participants with localized severe periodontal defects, the use of recombinant human platelet-derived growth factor (rhPDGF-BB) significantly improved clinical outcomes, with 87% of patients in the 0.3 mg/mL group achieving a composite success benchmark compared to only 53.8% in the control group.

The study demonstrated that rhPDGF-BB treatment leads to long-term stability in clinical attachment levels and bone growth, indicating its effectiveness in promoting periodontal regeneration over an extended period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. Nevins, M., Kao, RT., McGuire, MK., et al.[2022]

In a study involving 30 patients with chronic periodontitis, both platelet-rich fibrin (PRF) and enamel matrix derivative (EMD) were effective in treating periodontal intrabony defects, showing improvements in clinical parameters after 6 months.

However, EMD demonstrated a significantly greater percentage of defect resolution (43.07%) compared to PRF (32.41%), indicating that EMD may be the more effective option for this type of periodontal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich fibrin vs. enamel matrix derivative in the treatment of periodontal intrabony defects: a clinical and cone beam computed tomography study. Gupta, SJ., Jhingran, R., Gupta, V., et al.[2022]

Recombinant human growth hormone (rhGH) has been deemed safe for approved uses in both children and adults, according to a consensus from the GH Research Society, but ongoing monitoring for long-term safety issues is essential.

Recent discussions among leading endocrine societies emphasize the need for continued surveillance regarding potential risks associated with rhGH, including cancer, glucose metabolism, and cardiovascular health, especially in adults who were treated as children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults. Allen, DB., Backeljauw, P., Bidlingmaier, M., et al.[2022]

The growth-factor enhanced matrix (GEM) is a new clinical technology that combines recombinant human platelet-derived growth factor (rhPDGF-BB) with a bone scaffold, designed to enhance wound healing and bone regeneration.

Clinical and animal studies show that GEM effectively promotes wound healing, bone regeneration, and improves gingival attachment in difficult periodontal and peri-implant defects, highlighting its potential as a powerful treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new era in periodontal and periimplant regeneration: use of growth-factor enhanced matrices incorporating rhPDGF. Lynch, SE., Wisner-Lynch, L., Nevins, M., et al.[2018]

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) significantly improved linear defect fill (LDF) by 0.95 mm and clinical attachment level (CAL) gain by 0.34 mm compared to the control, indicating its efficacy in treating periodontal intra-bony defects.

Recombinant human fibroblast growth factor-2 (rhFGF-2) also showed significant improvement in LDF, with a 21.22% increase, suggesting it is effective as well, although rhPDGF-BB had a more pronounced effect overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of regenerative treatment with rhPDGF-BB and rhFGF-2 for periodontal intra-bony defects: a systematic review and meta-analysis. Khoshkam, V., Chan, HL., Lin, GH., et al.[2018]

In a study of 514 prepubertal children with idiopathic isolated growth hormone deficiency (GHD), baseline insulin-like growth factor-I (IGF-I) levels and stimulated peak growth hormone (GH) responses were found to be significant predictors of height velocity (HV) during the first year of rhGH treatment.

Children with moderate GHD showed an expected height velocity of 8.3 cm/year, indicating that identifying the severity of GHD through GH and IGF-I measurements can help tailor treatment strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corroboration of Height Velocity Prediction Markers for rhGH With an Oral GH Secretagogue Treatment in Children With GHD. Blum, WF., Bright, GM., Do, MT., et al.[2022]

Citations

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Enamel matrix derivative (Emdogain®) for periodontal tissue ... EMD is an extract of enamel matrix and contains amelogenins of various molecular weights. Amelogenins are involved in the formation of enamel and periodontal ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1882761624000140

Enamel matrix derivative monotherapy versus combination ... This systematic review evaluated the effectiveness of combining enamel matrix derivative (EMD) with various bone grafts in periodontal regenerative surgery.

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Long-term clinical outcomes of periodontal regeneration ... The present results have shown that in intrabony defects, the clinical improvements obtained following regenerative surgery with EMD can be maintained on a ...

4. frontiersin.org frontiersin.org/journals/dental-medicine/articles/10.3389/fdmed.2025.1611402/pdf

Research progress of enamel matrix derivative on ... Their findings indicated that both treatment modalities resulted in significant clinical and radiographic improvements over a 24-month period, ...

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Long‐term clinical outcomes of periodontal regeneration with ... The present study indicated that regenerative periodontal therapy of intrabony defects using EMD alone yielded positive clinical outcomes that ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040013b.pdf

summary of safety and effectiveness data - accessdata.fda.gov A combination of platelet derived growth factor and insulin like growth factor enhances periodontal regeneration. J Clin Periodontal, 1989; 16: ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5715458/

Platelet-Derived Growth Factor Promotes Periodontal ... The 6-month follow-up evaluation demonstrated that the use of rhPDGF-BB was safe and effective in the treatment of periodontal osseous defects. A similar study ...

8. sigmagraft.com sigmagraft.com/wp-content/uploads/2024/10/publication_Recombinant-human-platelet-derived-growth.pdf?srsltid=AfmBOorhUouMFUzetLEFCH013dGTLu86bSySEezvJK8ezavvmN4ji6EY

Recombinant human platelet-derived growth factor-BB– ... Results: A total of 10 patients exhibiting 13 advanced peri-implantitis-related bone defects were included. Implant survival at the 1-year follow-up was 100%.

9. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/abs/10.1002/cap.10212

The use of recombinant human platelet‐derived growth factor ... These case reports of combining rhPDGF-BB with β-TCP or with FDBA and a barrier membrane support the literature showing improvement in attachment levels.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7961612/

Recombinant Human Platelet–Derived Growth Factor Clinicians should be aware that rhPDGF is a safe and effective approach for the treatment of intrabony and furcation periodontal defects and gingival recession ...