Minimally Invasive Flap Procedure + Emdogain for Gum Disease

Overseen By Carlos Parra, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Must not be taking: Healing inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Serious medical conditions, others

Compensation: Varies

Number of Visits: 5

Duration: 1 day

32 Participants Needed

Trial Summary

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 are taking medications that are known to inhibit or slow healing.

What data supports the effectiveness of the treatment Minimally Invasive Flap Procedure + Emdogain for Gum Disease?

Research shows that Emdogain, an enamel matrix derivative, can help regenerate periodontal tissues, leading to improved healing and reduced inflammation after gum surgery. Clinical trials have indicated that using Emdogain with surgical procedures can result in better outcomes compared to surgery alone. ^{1 2 3 4 5}

Is the Minimally Invasive Flap Procedure with Emdogain safe for treating gum disease?

Research shows that Emdogain, used in gum disease treatments, generally has a good safety profile with no reported complications like allergic reactions or infections in studies. However, there have been rare cases of external inflammatory resorption, a condition where the root of the tooth is damaged, following its use. ^{1 3 5 6 7}

How does the treatment Minimally Invasive Flap Procedure + Emdogain for gum disease differ from other treatments?

This treatment is unique because it combines a minimally invasive surgical approach with Emdogain, an enamel matrix protein derivative, which promotes the regeneration of periodontal tissues and improves healing by reducing inflammation. Emdogain has been shown to enhance the regeneration of the periodontium, leading to better outcomes compared to surgery alone. ^{1 2 3 6 7}

What is the purpose of this trial?

This trial tests if using Emdogain® MI gel in a minimally invasive gum procedure can improve healing and attachment of gums in patients with moderate gum disease. The gel is applied after cleaning the roots of the teeth to help reduce inflammation and promote reattachment. Emdogain has been used in various clinical studies to promote periodontal tissue regeneration, including cementum, periodontal ligament, and alveolar bone.

Eligibility Criteria

This trial is for adults aged 30-75 with moderate gum disease, specifically isolated pocket depths of 5-7 mm on certain teeth and at least 2 mm of attachment loss. Participants should be in good health, not have had antibiotics or gum treatments recently, smoke less than 10 cigarettes a day, and not be pregnant or breastfeeding.

Inclusion Criteria

I have gum disease with some areas around my teeth measuring 5 to less than 7 mm deep.

At least 2 mm of attachment loss

Good health

Exclusion Criteria

Smoke more than ten cigarettes per day

Breastfeeding

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a non-incised minimally invasive flap procedure with Emdogain® MI or traditional SRP with videoscope visualization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 1 week, 3 months, and 6 months

6 months

3 visits (in-person)

Postoperative Evaluation

Postoperative evaluation at 1 week to reinforce oral hygiene and take photographs

1 week

1 visit (in-person)

Treatment Details

Interventions

• Minimally invasive periodontal therapy without the use of Emdogain
• Minimally invasive periodontal therapy with use of Emdogain

Trial Overview The study tests a minimally invasive flap procedure to treat gum disease using Emdogain® MI versus the same procedure without Emdogain. It involves removing part of the sulcus lining and cleaning the root surface with visual aid from a videoscope.

Participant Groups

Group I: Periodontal regeneration Experimental Treatment 1 Intervention

Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.

Group II: Control Placebo Group 1 Intervention

The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Institut Straumann AG

Industry Sponsor

Trials

54

Recruited

2,700+

Findings from Research

Emdogain, a treatment derived from porcine enamel matrix proteins, has been effective in regenerating periodontal tissues in humans, promoting new cementum, periodontal ligament, and bone formation.

However, this case report highlights a potential adverse effect: external inflammatory root resorption, which was observed in two patients 6-24 months after treatment, suggesting that while Emdogain can be beneficial, it may also carry risks that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory external root resorption following surgical treatment for intra-bony defects: a report of two cases involving Emdogain and a review of the literature. St George, G., Darbar, U., Thomas, G.[2006]

Emdogain, an enamel matrix derivative, significantly reduces the vitality of supragingival dental plaque, suggesting it may have an antibacterial effect that contributes to improved healing after periodontal surgery.

In a study involving 24 patients with adult periodontitis, Emdogain showed a greater reduction in plaque vitality compared to chlorhexidine, indicating its potential as an effective antimicrobial treatment in periodontal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an enamel matrix protein derivative (Emdogain) on ex vivo dental plaque vitality. Sculean, A., Auschill, TM., Donos, N., et al.[2019]

Emdogain, an enamel matrix protein, has been shown to enhance the regeneration of the periodontium, promoting cementogenesis and tissue healing in both animal and human studies.

Clinical trials indicate that using Emdogain in conjunction with modified Widman flap surgery yields better outcomes than surgery alone, although further validation is needed for its effectiveness compared to other methods like bioabsorbable membranes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emdogain: evidence of efficacy. Greenstein, G.[2011]

The use of Emdogain in treating deep periodontal pockets resulted in a significant reduction in probing depth and attachment level after 12 months, indicating improved clinical outcomes for patients with intrabony defects.

Despite the clinical improvements, radiologic assessments did not show significant changes, and histological examinations did not provide evidence of new attachment, suggesting that further research is needed to understand the long-term efficacy and mechanism of action of Emdogain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Emdogain in the treatment of deep intrabony defects: 12-month clinical results. Histologic and radiographic evaluation. Parodi, R., Liuzzo, G., Patrucco, P., et al.[2016]

Enamel matrix derivative (EMD) is effective in regenerating periodontal tissue, primarily due to its high content of amelogenin proteins, which enhance cell behavior such as proliferation and differentiation, especially in periodontal ligament and osteoblastic cells.

While EMD shows a strong regenerative response, its individual components, amelogenin and ameloblastin, only partially replicate these effects, suggesting that the full EMD complex works synergistically to promote tissue regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. Grandin, HM., Gemperli, AC., Dard, M.[2012]

In a study involving 28 patients with periodontitis, the application of Emdogain significantly reduced probing pocket depth from 8.7 mm to 4.3 mm after 8 months, indicating effective treatment for intrabony periodontal defects.

The treatment was safe, with no complications reported, and resulted in new hard tissue formation in 26 out of 32 defects, suggesting promising regenerative potential for Emdogain in periodontal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of intrabony periodontal defects with an enamel matrix protein derivative (Emdogain): a report of 32 cases. Sculean, A., Reich, E., Chiantella, GC., et al.[2004]

In a 5-year study involving 15 patients with chronic periodontitis, the use of Emdogain® as an adjunct to open flap debridement led to a significantly greater reduction in Probing Pocket Depth (PPD) compared to the control group, with a mean reduction of 3.84 mm versus 1.92 mm.

The test group treated with Emdogain® also showed a mean Clinical Attachment Level (CAL) gain of 3.18 mm, significantly higher than the control group's gain of 1.60 mm, indicating that Emdogain® effectively promotes periodontal regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: a randomized controlled trial. Bhutda, G., Deo, V.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inflammatory external root resorption following surgical treatment for intra-bony defects: a report of two cases involving Emdogain and a review of the literature. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of an enamel matrix protein derivative (Emdogain) on ex vivo dental plaque vitality. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Emdogain: evidence of efficacy. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Emdogain in the treatment of deep intrabony defects: 12-month clinical results. Histologic and radiographic evaluation. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of intrabony periodontal defects with an enamel matrix protein derivative (Emdogain): a report of 32 cases. [2004]

7. England pubmed.ncbi.nlm.nih.gov

Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: a randomized controlled trial. [2013]