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The aim of the current study is to compare lateral bone augmentation using the current gold standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone material.
One of the major problems in implant therapy is the need to regenerate bone after its resorption because of periodontal disease, traumatic extraction or surgical removal associated with treatment of invasive lesions.
Ossix Volumax is a novel volume maintaining collagen scaffold designed for bone augmentation in the atrophic ridge. It is 1-2 mm in thickness and undergoes mineralization progressing into ossification.
Thirty subjects requiring lateral bone augmentation of the maxilla or the mandible will be recruited study: Of these, twenty will be recruited and treated at the School of Dental Medicine, Harvard University, Boston, USA and ten (10) at the School of Graduate Dentistry, Rambam health care campus, Haifa, Israel.
Hypothesis:
The use of Ossix Volumax as a stand-alone augmentation material will results similar increase in the ridge width and volume compared to FDBA and barrier membrane when coupled together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ossix Volumax | Experimental | lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax) |
|
| FDBA with collagen membrane | Active Comparator | lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossix Volumax | Device | Ossix Volumax is intended to be used for Lateral ridge augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in socket width mm | Clinical measurement of the ridge width as -2, -5 & -8 mm from crest at the Region of interest (ROI) using a caliper | baseline( prior to augmentation) and 9 months (implant placement) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Ridge height mm | Ridge height from a pre-determined landmark using a 15mm Dental probe | baseline( prior to augmentation) and 9 months (implant placement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eli Machtei, DMD | Contact | 9727772983 | machtei@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Eli Machtei, DMD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus, Dept. of Periodontology | Recruiting | Haifa | 31096 | Israel |
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| FDBA with collagen membrane | Device | freeze-dried bone allograft (FDBA) with collagen membrane |
|