MicroDerm for Gum Recession
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, Alloderm and MicroDerm (a type of tissue graft), to determine which is more effective for gum recession. It evaluates how well each treatment heals wounds, covers exposed roots, improves gum coverage, boosts blood flow, and enhances patient comfort. Individuals with gum recession who need a tissue graft may qualify, provided they do not smoke, have diabetes, use certain medications, or have poor oral hygiene. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
If you are taking anticoagulant or antiplatelet medications, you will need to stop taking them to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What is the safety track record for Alloderm and MicroDerm?
Research has shown that MicroDerm, or microsurfaced Acellular Dermal Matrix (mADM), is generally well-tolerated. Studies suggest it may effectively treat gum recession by thickening gums and covering exposed roots.
Alloderm, another treatment in this study, is also commonly used in similar gum procedures and has shown success with few reported side effects. As this trial is in Phase 4, both treatments have already been tested on many people, indicating a strong safety record. Overall, both MicroDerm and Alloderm appear to be safe options for treating gum issues.12345Why are researchers enthusiastic about this study treatment?
MicroDerm is unique because it uses a specially engineered material as a soft tissue graft for treating gum recession. Unlike traditional treatments like AlloDerm, which is derived from donated human tissue, MicroDerm offers a synthetic alternative that may reduce the risk of immune rejection and improve healing times. Researchers are excited because MicroDerm could provide a more consistent and potentially safer option for patients, making gum recession treatment more accessible and effective.
What evidence suggests that this trial's treatments could be effective for gum recession?
In this trial, participants will receive either MicroDerm or Alloderm as a soft tissue grafting material for gum recession. Research has shown that MicroDerm, a special material used in dental procedures, can significantly aid receding gums. Specifically, studies found that patients using MicroDerm experienced a reduction in gum recession from an average of 3.64 mm to 0.73 mm over a year, resulting in more tooth root coverage. Alloderm, a commonly used material for gum treatments, is already effective in dental procedures. Both treatments have improved gum coverage, but recent findings suggest that MicroDerm might offer even better results.23678
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need a tissue graft due to gum recession. It's not for those with previous soft tissue grafts, pregnant or breastfeeding women, smokers, diabetics (HbA1c > 5.6%), people with poor oral hygiene (PII >2), history of certain cancer treatments or bisphosphonate therapy, and those on blood thinners or allergic to study medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either microsurfaced Acellular Dermal Matrix (mADM) or Acellular Dermal Matrix (ADM) for root coverage procedures
Follow-up
Participants are monitored for wound healing, root coverage, gum tissue coverage, blood flow, and patient comfort
What Are the Treatments Tested in This Trial?
Interventions
- Alloderm
- MicroDerm
Trial Overview
The study compares two types of dermal matrices used in dental surgery: standard Acellular Dermal Matrix (ADM) and microsurfaced ADM (mADM). The focus is on how well they heal wounds, cover roots and gums after surgery, improve blood flow to the area, and patient comfort during recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The subjects in this arm will receive microderm as a soft tissue grafting material
The patients in this group will receive alloderm as a soft tissue grafting material
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Citations
Root coverage using a microsurfaced acellular dermal matrix: A ...
Eleven RT1 gingival recession defects from five patients were treated using mADM between January and May 2023 by a single surgeon (S.R.). A modified vestibular ...
2.
researchgate.net
researchgate.net/publication/394066240_Root_coverage_using_a_microsurfaced_acellular_dermal_matrix_A_retrospective_case_seriesRoot coverage using a microsurfaced acellular dermal matrix
Pair t‐tests were utilized to compare changes overtime. Results The mean recession depth reduced from 3.64 ± 0.50 mm to 0.73 ± 0.79 mm after 12 months.
Micro-needling versus acellular dermal matrix in RT1 ...
Results: Both groups independently demonstrated significant gain in GT, RW, RD, CAL, PD, Rec-Red, CRC and percentage of root coverage, with ...
Root coverage using a microsurfaced acellular dermal matrix
The purpose of this report is to describe the usage of. mADM in the treatment of gingival recession for root cov- erage in five cases with ...
Clinical Innovation in Periodontics: Promising Results for ...
A new case series published in Clinical Advances in Periodontics evaluated the use of microsurfaced acellular dermal matrix (mADM) for treating RT1 gingival ...
Micro‐needling versus acellular dermal matrix in RT1 ...
Recession coverage procedures yield more predictable long-term results when accompanied by an increased gingival thickness and keratinized ...
MicroDerm for Gum Recession
This Phase 4 medical study run by Ohio State University is evaluating whether Alloderm and MicroDerm will have tolerable side effects & efficacy for ...
8.
researchgate.net
researchgate.net/publication/380097977_Micro-needling_versus_acellular_dermal_matrix_in_RT1_gingival_recession_coverage_A_randomized_clinical_trial(PDF) Micro-needling versus acellular dermal matrix in ...
Micro-needling versus acellular dermal matrix in RT1 gingival recession coverage: A randomized clinical trial. April 2024; Journal of ...
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