The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane
The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.
Department of Periodontology Hadassah and Hebrew University Medical Center
Jerusalem, Israel
RECRUITINGBone volume
Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by "subtraction" of the 2 cone beam CTs using digital measurements.
Time frame: Change from Baseline in bone volume at 6 months
Histomorphometry
Specimens will be prepared for histological staining (H\&E and Masson's trichrome stain). The stained samples will be evaluated for new bone, residual bone graft, marrow spaces and vascularity.
Time frame: 6 months
Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant
Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant
Time frame: six months
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