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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.

Summary

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.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Attachment level change.
Biofilm presence change.
Bleeding on probing change.
+2 more
Secondary study objectives
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.

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.

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
149 Previous Clinical Trials
26,435 Total Patients Enrolled
Institut Straumann AGIndustry Sponsor
53 Previous Clinical Trials
2,637 Total Patients Enrolled

Media Library

Periodontal regeneration Clinical Trial Eligibility Overview. Trial Name: NCT05964699 — N/A
Gum Disease Research Study Groups: Periodontal regeneration, Control
Gum Disease 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
Gum Disease Patient Testimony for trial: Trial Name: NCT05964699 — N/A
~9 spots leftby Jul 2025