Acellular Dermal Matrix for Bone Grafts
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two materials to determine which better aids bone regrowth in areas with a thin jawbone. It compares acellular dermal matrix (ADM) and a resorbable collagen membrane to evaluate their effectiveness as protective covers for bone grafts. Suitable participants have healthy teeth or dental implants on both sides of a gap needing bone regrowth for future dental implants and are patients at the UAB Dental School.
As an unphased trial, this study allows participants to contribute to innovative dental research that could enhance future treatments.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have uncontrolled diabetes, untreated periodontal disease, or are taking IV bisphosphonates, you may not be eligible to participate.
What prior data suggests that these barriers are safe for guided bone regeneration?
Previous studies have shown that the acellular dermal matrix (ADM) is a safe option for aiding bone regrowth. Research indicates that ADM has been used for over ten years in more than 500 cases without any reports of viral transmission, suggesting it is well-tolerated by patients. Additionally, ADM is often considered a safe alternative to using the patient's own tissue for grafts.
Resorbable cross-linked collagen membranes, such as Mem-Lok, are also used in dental procedures. These membranes dissolve in the body over time, reducing the need for additional surgery to remove them, which enhances their safety. Overall, both treatments have a history of safe use and are generally well-accepted by patients.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for guided bone regeneration because they offer innovative solutions to improve bone grafting outcomes. The use of Acellular Dermal Matrix (ADM) as a barrier is unique because it provides a stable and effective environment for bone healing by fully covering the augmented site and ensuring proper space maintenance with titanium tacks or periosteal sutures. Unlike traditional collagen membranes, ADM offers a biologically active scaffold that can enhance tissue integration. Additionally, the Resorbable Cross-linked Collagen Membrane (RCM) provides a flexible yet durable option that naturally resorbs after supporting the graft, minimizing the need for additional surgery to remove the barrier. These advancements aim to enhance the effectiveness and ease of bone regeneration procedures.
What evidence suggests that this trial's treatments could be effective for guided bone regeneration?
In this trial, participants will receive either Acellular Dermal Matrix (ADM) or a Resorbable Cross-linked Collagen Membrane as part of guided bone regeneration procedures. Research has shown that ADM effectively aids bone healing by acting as a supportive layer. Studies have found that ADM provides strong support for soft tissue, which is crucial for bone healing. A review of multiple studies confirmed that ADM improves soft tissue, essential for successful bone grafts. ADM has been used safely in thousands of cases without spreading viruses, making it a reliable choice for enhancing bone and tissue healing.
For the Resorbable Cross-linked Collagen Membrane, research suggests it also functions well as a barrier to support bone growth. This membrane maintains the space needed for proper bone growth by covering the grafted area and gradually dissolves, aligning with the body's natural healing process. Both ADM and collagen membranes have effectively supported bone and tissue repair, but their success can vary depending on each patient's needs and conditions.13467Who Is on the Research Team?
Maria L Geisinger, DDS, MS
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults needing bone grafts to rebuild areas of jawbone that have shrunk, usually in preparation for dental implants. People with certain health conditions or factors that could affect healing may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Guided Bone Regeneration using either ADM or resorbable collagen membranes for horizontal ridge augmentation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including soft tissue thickness and patient-centered outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Acellular Dermal Matrix (ADM)
- Resorbable Cross-linked Collagen Membrane
Trial Overview
The study compares two materials used as barriers during guided bone regeneration: acellular dermal matrix (AlloDerm) and a resorbable crosslinked collagen membrane (Mem-Lok), to see which helps the bone heal better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. Following decortication and graft placement to reconstruct the horizontal ridge deficiency, acellular dermal matrix (ADM) will be adapted to fully cover the augmented site with appropriate extension beyond the defect margins. The ADM will be stabilized using titanium tacks and/or periosteal sutures as needed to ensure space maintenance and membrane stability.
GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. The graft will be contoured to reconstruct the horizontal ridge deficiency following decortication of the recipient site. A resorbable collagen membrane \[Mem-Lok® Resorbable Collagen Matrix (RCM) will be trimmed and positioned to fully cover the grafted area with extension beyond the defect margins and stabilized using titanium tacks and/or periosteal sutures as needed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
Acellular dermal matrix as a barrier in guided bone ...
The purpose of this study was to evaluate the effectiveness of the acellular dermal matrix (ADM) as a membrane for guided bone regeneration (GBR), in comparison ...
2.
ctv.veeva.com
ctv.veeva.com/study/evaluating-the-barrier-function-regenerative-capacity-and-soft-tissue-outcomes-of-acellular-dermalEvaluating the Barrier Function, Regenerative Capacity, and ...
This investigator-initiated study will compare ADM and resorbable collagen membrane barrier for guided bone regeneration.
Efficacy of Acellular Dermal Matrix in Soft Tissue ...
This study was done to perform a systematic review and meta-analysis of the studies on the efficacy of acellular dermal matrix (ADM) in.
Acellular Dermal Matrix - an overview
This material is considered to be a safe alternative to autograft since no cases of viral transmission have been reported in ten years of use in more than 500 ...
Acellular Dermal Matrix as a Treatment Option for Guided ...
Acellular Dermal Matrix as a Treatment Option for Guided Bone Regeneration. Clinical application demonstrates improved soft tissue support ...
Evaluating the Barrier Function, Regenerative Capacity ...
This investigator-initiated study will compare ADM and resorbable collagen membrane barrier for guided bone regeneration.
AlloDerm® Regenerative Tissue Matrix
AlloDerm is an acellular dermal matrix derived from donated human skin that undergoes a multi-step proprietary process that removes both.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.