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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 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.
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 moreSecondary 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gum disease with some areas around my teeth measuring 5 to less than 7 mm deep.I have two teeth with deep gum pockets in different areas of my mouth.I haven't taken antibiotics in the last 90 days.I have two teeth with deep gum pockets in different areas of my mouth.I am between 30 and 75 years old.I have had gum treatment in the past 6 months.I am not on medications that slow down healing.You should be in overall good health.
Research Study Groups:
This trial has the following groups:- Group 1: Periodontal regeneration
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Gum Disease Patient Testimony for trial: Trial Name: NCT05964699 — N/A