Grafting for Alveolar Bone Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years. In order to ensure successful implant therapy, adequate bone and soft tissue as well as correct 3D positioning of the implant are required. Upon extraction of a tooth, socket width can decrease by up to 60% within six months post-extraction, with a 11-22% vertical reduction. Additionally, sinus pneumatization occurs post-extraction as the maxillary sinus expands into the empty socket due to disuse atrophy and intra-sinus air pressure, as explained by Wolff's law. This further reduces residual bone height (RBH), often resulting in posterior maxillary sites requiring supplemental procedures to prevent bone loss or to augment the bone height at the time of implant placement. However, if the bone height and width dimensions are sufficient before and after extraction - in that, even with the aforementioned loss in width and height percentages in the latter, a standard implant may still be placed in the surrounding bone, one can argue that grafting may not be necessarily done at the time of extraction. Rather, it can be tailored to the patients' needs; thus potentially reducing overall post-operative discomfort and pain.
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?
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
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
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