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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for gum disease using a minimally invasive technique. Researchers compare a standard gum cleaning method with a new approach that uses Emdogain, a special gel, and a videoscope to clean tooth roots more effectively. The trial seeks individuals with gum disease who have specific gum pocket sizes and some gum tissue loss. Participants should be generally healthy, smoke fewer than 10 cigarettes a day, and not have received antibiotics or gum treatments recently. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future gum disease treatments.

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 prior data suggests that this minimally invasive flap procedure is safe for gum disease treatment?

Previous studies have shown Emdogain to be safe. Research indicates that using Emdogain to treat gum disease has not resulted in reports of serious issues like allergic reactions, suggesting patients generally tolerate it well. Additionally, research shows that combining Emdogain with gentle techniques for gum disease improves results without compromising safety. Thus, past data suggest the treatment is safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for gum disease because they incorporate Emdogain, a special protein-based gel that can enhance tissue regeneration. Unlike traditional methods that solely focus on cleaning and smoothing the tooth roots, this approach aims to actively regenerate gum tissue and bone, potentially reversing damage caused by periodontal disease. The use of a videoscope in conjunction with Emdogain also offers improved visibility during the procedure, which can lead to more precise treatment and better outcomes. This innovative combination could offer a more effective and less invasive solution for patients suffering from gum disease.

What evidence suggests that this trial's treatments could be effective for gum disease?

Studies have shown that Emdogain, a special gel, may help regrow tissue supporting teeth lost due to gum disease. Research indicates a success rate of 30.9% at 6 months and 42.6% after about 10 years. This trial will compare two approaches: one group will receive minimally invasive periodontal therapy with Emdogain, while the control group will undergo standard root scaling and planing without it. Emdogain is used alongside procedures to clean and smooth the tooth's root, aiming to improve gum health and promote tissue regrowth. While promising, more studies are needed to fully understand its benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

At least 2 mm of attachment loss

Good health

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

Exclusion Criteria

Smoke more than ten cigarettes per day

Breastfeeding

Pregnant

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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