An interventional study of BioMend Extend and Modified BioMend Extend in Alveolar Ridge Augmentation, sponsored by Stony Brook University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.
Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment
Guided bone regeneration (GBR) procedures have significantly evolved over the last 20 years. Significant advances have been made with various barrier membranes with or without the use of bone grafts and other materials. Some of the main limitations of non-resorbable barriers included cytotoxicity and need for removal, which can adversely affect the regenerated bone volume. Similar GBR success has been documented extensively with cell occlusive resorbable barriers membranes. Recently, the investigators demonstrated supracrestal bone regeneration in guided tissue regeneration procedures in humans with the use of novel perforated barrier membrane (MPM). The perforation allows mesenchymal stem cells and other progenitor cells present in the gingival tissues to migrate into the osseous defect and contribute to the osseous regeneration potential.
The objective of this study is to investigate the GBR potential of MPM in alveolar ridge defects, relative to a similar occlusive barrier. Ten non-smoking patients that need localized alveolar ridge augmentation prior to implant placement will be included into the study. Patients will be divided into two groups, as follows: occlusive bovine collagen membrane (OM control group, 5 patients) and modified bovine perforated collagen membrane (MPM test group, 5 patients). All sites will be grafted with mineralized cortical bone allograft and when needed cortical bone pins will be use for site stability. A Cone Bean (CT) will be obtained prior to surgery and 6-8 months post treatment from which volumetric width changes will be quantify. A bone biopsy will be obtained at the time of implant placement (\~6-8 months) to determine residual graft particles and new bone formation. Dimensional width changes will be assess at 6-8 months during re-entry for implant placement. Soft tissue healing will be assessed at 2, 4, 8, 16 weeks and 6 months.
This study can potentially impact current bone augmentation techniques and may lead to the modification of existing commercial membranes that will enhance site development prior to implant placement. The contribution of progenitor cells to the osseous defect might lead to greater bone formation and possible faster wound healing.
Stony Brook University is the lead sponsor of 197 studies on the registry; 37 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
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Exclusion Criteria:
Five patients will be randomly assigned to the OM group.
Other: BioMend Extend
Five patients will be randomly assigned to the MPM group.
Other: Modified BioMend Extend
Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration.
Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration. This membrane will be perforated to allow the passage of cells and growth factors that can potentially enhanced bone augmentation.
Clinical horizontal bone augmentation results through direct measurement.
Time frame: at 6 months post treatment
Volumetric measurements with CBCT
Time frame: pre- and 6 months post treatment
De novo bone formation, and residual graft particles quantification with histomorphometric analysis
Time frame: at 6 months post treatment
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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