Grafting for Alveolar Bone Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Ossix mineralized grafting to address bone loss in the jaw after tooth removal. The goal is to determine whether grafting immediately after tooth removal or later during implant placement better maintains bone height for successful dental implants. Individuals with at least 6 mm of bone height after tooth extraction and minimal surrounding damage may qualify. The trial seeks to reduce discomfort and improve outcomes for those needing dental implants. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future dental implant procedures.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this grafting method is safe for dental procedures?
Research has shown that the materials used in Ossix mineralized grafting are generally safe for patients. Studies have found that Ossix products, such as Ossix Plus and Ossix Agile, have received FDA approval and are frequently used in dental procedures. These materials are designed to be compatible with the body, meaning they integrate well and break down safely over time.
However, some important considerations exist. People allergic to collagen or materials derived from pigs should not use Ossix products. Although these allergies are rare, awareness is crucial.
Overall, the treatment is considered safe due to its regular use in dental care and FDA approval.12345Why are researchers excited about this trial?
Researchers are excited about the grafting treatments for alveolar bone loss because they utilize Ossix products, which are known for their advanced resorbable collagen membranes and bone graft materials. Unlike traditional grafting methods, these treatments use Ossix Plus and Ossix Agile, both FDA-approved and designed to integrate seamlessly with the body's natural healing processes. The Ossix products stand out for their ability to enhance bone regeneration while minimizing complications due to their resorbable nature, which means they gradually dissolve, eliminating the need for surgical removal. This innovative approach could lead to more efficient and comfortable recovery for patients undergoing dental procedures.
What evidence suggests that this trial's treatments could be effective for alveolar bone loss?
This trial will compare immediate grafting with delayed grafting using Ossix materials. Studies have shown that Ossix mineralized grafting effectively rebuilds jawbone, which is crucial for successful dental implants. Research indicates that Ossix products can result in an average of 43.8% new bone growth. More bone provides better support for dental implants. Additionally, case reports have demonstrated successful implant placements with strong tissue and bone support when using Ossix materials. Praised for their ease of shaping and stability, these materials aid in the reliable growth of new bone. Overall, research supports the use of Ossix grafting materials in dental procedures.14567
Who Is on the Research Team?
Iya Ghassib
Principal Investigator
Virginia Commonwealth University
Sandra Al-Tarawneh
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for adults needing a maxillary molar extraction who have at least 6 mm of bone height left, minimal damage to the socket walls (less than 5mm), and enough space between tooth roots and sinus. People with major bone loss or other dental complications are not eligible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Immediate Grafting
Participants receive immediate grafting using Ossix Plus and Ossix bone graft after extraction
Delayed Grafting
Grafting performed after extraction and at the time of implant placement using Ossix Agile and Ossix bone graft
Follow-up
Participants are monitored for clinical and radiographic outcomes post-implant
What Are the Treatments Tested in This Trial?
Interventions
- Ossix mineralized grafting
Trial Overview
The study compares two approaches: placing a mineralized bone graft right after tooth extraction versus waiting to place the graft later when the dental implant is put in. The goal is to see which method better preserves jawbone thickness and height.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subject will receive immediate grafting using Ossix Plus (FDA approved resorbable cross-linked collagen membrane) and Ossix bone graft (FDA approved). All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics.
Grafting will be performed after extraction and at the time of implant placement (T3, as referred to in the section on study timelines) using Ossix Agile® (FDA approved- resorbable collagen membrane), and Ossix bone graft (FDA approved). All materials utilized in this study are commercially available, FDA-approved, used in standard of care procedures and commercially available by Dentsply Sirona. They will be used in accordance with the manufacturer's labeling and instructions. These materials are currently used for ARP and grafting in the VCU clinics.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
Dentsply Sirona Inc.
Industry Sponsor
Citations
1.
regenerative.dentsplysirona.com
regenerative.dentsplysirona.com/wp-content/uploads/2025/04/DIGITAL-ROW-OSSIX-Booklet-MKT-0003426-VER-01.pdfPower of OSSIX® Products
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K212509 - Janice Hogan - accessdata.fda.gov
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