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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Ossix Volumax is intended to be used for Lateral ridge augmentation
freeze-dried bone allograft (FDBA) with collagen membrane
Rambam Health Care Campus, Dept. of Periodontology
Haifa, Israel
RECRUITINGChanges 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
Time frame: baseline( prior to augmentation) and 9 months (implant placement)
Changes in Ridge height mm
Ridge height from a pre-determined landmark using a 15mm Dental probe
Time frame: baseline( prior to augmentation) and 9 months (implant placement)
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