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Allogenic Dermal Matrix
Platelet-Rich Fibrin Treatment for Gum Recession
N/A
Waitlist Available
Led By Shayan Barootchi, DMD, MS
Research Sponsored by University of Michigan
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 assessed at 6 months
Awards & highlights
Study Summary
This trial tests a new treatment for gum recession that may be as effective as the current method.
Who is the study for?
Adults with healthy gums and overall health, who have not had root coverage procedures in the past year. They must have good oral hygiene, low plaque and bleeding scores, and at least one gingival recession of 3 mm or deeper needing surgery. Excluded are those with loose teeth, pregnancy or nursing women, untreated infections or malignancies at the site, blood disorders, severe co-morbidities, sensitivity to certain antibiotics or undergoing treatments that affect healing.Check my eligibility
What is being tested?
The trial is testing if using an Allogenic Dermal Matrix combined with Platelet-Rich Fibrin is as effective as the standard Connective Tissue Graft for treating gum recession. Participants will undergo a tunneled coronally advanced flap procedure where these materials are used to cover exposed roots.See study design
What are the potential side effects?
Possible side effects may include discomfort at the surgical site, swelling, bruising, infection risk increase due to surgery itself. Specific reactions to Platelet-Rich Fibrin or Allogenic Dermal Matrix could occur but are generally rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete root coverage (CRC)
Duration of surgical procedure
Gingival thickness (GT) gain
+3 moreSecondary outcome measures
Patient-reported esthetics
Patient-reported post-operative pain as measured with a mobile application
Patient-reported satisfaction
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Allogenic Dermal Matrix with Platelet-Rich FibrinExperimental Treatment1 Intervention
An allogenic dermal matrix with the patient's platelet-rich fibrin will be used
Group II: Connective Tissue GraftActive Control1 Intervention
A connective tissue graft from the patient's palate will be used
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
The treatment of gum recession often involves procedures that aim to regenerate lost gum tissue and improve attachment to the teeth. The Allogenic Dermal Matrix serves as a scaffold that supports tissue regeneration, while Platelet-Rich Fibrin (PRF) releases growth factors that promote healing and tissue growth.
This combination enhances the body's natural healing processes, leading to better outcomes in terms of tissue regeneration and stability. For patients, these treatments are crucial as they not only improve the aesthetic appearance of the gums but also restore the protective function of the gum tissue, reducing sensitivity and the risk of further recession.
Root Coverage Predictability in the Treatment of Gingival Recessions on Mandibular Anterior Teeth.
Root Coverage Predictability in the Treatment of Gingival Recessions on Mandibular Anterior Teeth.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,809 Previous Clinical Trials
6,385,057 Total Patients Enrolled
Shayan Barootchi, DMD, MSPrincipal InvestigatorUniversity of Michigan
Hom-Lay Wang, DDS MSD PhDPrincipal InvestigatorUniversity of Michigan
6 Previous Clinical Trials
247 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have gum surgery due to health reasons.My teeth are very loose or have severe gum damage.I have a history of blood disorders like abnormal clotting.I am an adult with healthy gums and no systemic health issues.I have serious health issues like obesity, uncontrolled diabetes, or weak immunity.I have deep gum recession needing surgery to cover the root.I have ongoing gum damage from brushing my teeth too hard.I have severe tooth misalignment or noticeable tooth eruption.I haven't had any gum grafting procedures in the past year.I am not allergic to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, or Vancomycin.I have untreated gum disease or infections at the surgery area.I currently smoke more than 10 cigarettes a day or use tobacco/vape regularly.I have cancer that hasn't been treated at the surgery area.
Research Study Groups:
This trial has the following groups:- Group 1: Allogenic Dermal Matrix with Platelet-Rich Fibrin
- Group 2: Connective Tissue Graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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