What side effects are associated with this type of intervention?

Common treatments for periodontal attachment loss, such as those involving enamel matrix derivatives like Emdogain® MI, generally have mild side effects. These can include temporary discomfort or pain at the treatment site, swelling, and minor bleeding. In some cases, patients may experience sensitivity to hot or cold temperatures. Infection is a rare but possible complication. Overall, these treatments are well-tolerated, with most side effects being transient and manageable.

What prior FDA approvals exist?

The FDA has approved several treatments for periodontal attachment loss that focus on promoting periodontal regeneration. One notable treatment is Emdogain® (Enamel Matrix Derivative), which mimics natural tooth development processes to regenerate periodontal tissues. This treatment has been shown to enhance the formation of new bone, cementum, and periodontal ligament. Other similar treatments include bone grafts, guided tissue regeneration (GTR), and the use of growth factors like platelet-derived growth factor (PDGF) and bone morphogenetic proteins (BMPs), which also aim to stimulate the body's natural regenerative processes to restore periodontal structures.

What other types of research exist?

Promising novel alternatives to Emdogain® MI for periodontal attachment loss patients in 2024 include: 1) Stem cell therapy, which uses mesenchymal stem cells to promote tissue regeneration and healing. 2) Growth factors such as platelet-derived growth factor (PDGF) and bone morphogenetic proteins (BMPs) that enhance periodontal regeneration. 3) Biomimetic scaffolds and hydrogels that provide structural support and promote cell growth and differentiation. These alternatives have shown potential in clinical trials and are expected to be viable treatment options.

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Minimally Invasive Flap Procedure + Emdogain for Gum Disease

N/A

Recruiting

Research Sponsored by Texas A&M University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.

Awards & highlights

Study Summary

This trial studies a modified approach to a minimally invasive periodontal procedure, using a videoscope to better view and debride root surfaces. The goal is to improve the traditional "gingival curettage" technique.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, swelling or bruising of gums, infection risk due to curettage, and possible allergic reactions to Emdogain if used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attachment level change.

Biofilm presence change.

Bleeding on probing change.

+2 more

Secondary outcome measures

Time necessary to perform the test procedures

VAS pain scale 1 week after appointment.

VAS pain scale 24 hours after appointment.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Periodontal regenerationExperimental Treatment1 Intervention

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

Group II: ControlPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for periodontal attachment loss include scaling and root planing, antimicrobial therapy, and regenerative procedures. Emdogain® MI, an enamel matrix derivative, promotes periodontal regeneration by mimicking natural tooth development processes, encouraging the formation of new bone, cementum, and periodontal ligament. This is crucial for patients as it not only halts disease progression but also restores the structural integrity and function of the periodontium, leading to improved oral health and stability of teeth.

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Who is running the clinical trial?

Texas A&M UniversityLead Sponsor

140 Previous Clinical Trials

24,325 Total Patients Enrolled

1 Trials studying Periodontal Attachment Loss

20 Patients Enrolled for Periodontal Attachment Loss

Institut Straumann AGIndustry Sponsor

53 Previous Clinical Trials

2,637 Total Patients Enrolled

1 Trials studying Periodontal Attachment Loss

35 Patients Enrolled for Periodontal Attachment Loss

Media Library

Periodontal regeneration Clinical Trial Eligibility Overview. Trial Name: NCT05964699 — N/A

Periodontal Attachment Loss Research Study Groups: Periodontal regeneration, Control

Periodontal Attachment Loss Clinical Trial 2023: Periodontal regeneration Highlights & Side Effects. Trial Name: NCT05964699 — N/A

Periodontal regeneration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964699 — N/A

Periodontal Attachment Loss Patient Testimony for trial: Trial Name: NCT05964699 — N/A

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