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Regenerative Tissue Matrix
Tissue Matrix + Enamel Matrix for Gum Recession
Phase 4
Recruiting
Led By Bindu Dukka, BDS, MSD, MPH
Research Sponsored by University of Louisville
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 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will compare treatments to improve gum recession in 24 patients, measuring improvements in 6 months.
Who is the study for?
This trial is for healthy adults over 18 with certain types of gum recession who can sign a consent form. It's not for those allergic to study materials, on long-term steroids, with alcohol issues, pregnant or breastfeeding women, poor oral hygiene, recent cancer treatments, tobacco users, or those with diseases affecting gums.
What is being tested?
The study tests if adding Enamel Matrix Derivative to AlloDerm RTM improves gum recession treatment outcomes. It measures changes in gum coverage and health at baseline and after 6 months in two groups: one using both treatments and one using only the regenerative tissue matrix.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to materials used (if any), infection due to dental procedures involved in the trial or discomfort related to the treatment process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recession defect coverage
Secondary study objectives
Clinical attachment levels
Body tissue
Soft tissue thickness
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix DerivativeExperimental Treatment2 Interventions
12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons) and a porcine derived enamel matrix derivative (Emdogain, Straumann).
Group II: Coronally positioned tunnel with AlloDerm RTMActive Control1 Intervention
12 patients will receive a coronally positioned tunnel with a regenerative tissue matrix (AlloDerm RTM, BioHorizons).
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
345 Previous Clinical Trials
77,391 Total Patients Enrolled
Bindu Dukka, BDS, MSD, MPHPrincipal InvestigatorDirector, Graduate Periodontics, University of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol abuse.Your cemento-enamel junction cannot be clearly identified.You have had dental restorations done on the root surface where the gum has receded.You are not allowed to use any form of tobacco, including smoking, chewing tobacco, or using e-cigarettes.You have severe conditions that affect your entire body, oral health, or mental well-being, which could make it difficult for you to participate in the study.You have had a previous surgery or treatment to address gum recession at the same area.
Research Study Groups:
This trial has the following groups:- Group 1: Coronally positioned tunnel with AlloDerm RTM and Enamel Matrix Derivative
- Group 2: Coronally positioned tunnel with AlloDerm RTM
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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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