Bone Regeneration Clinical Trial
Official title:
Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space
Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient
dimension to permit dental implant placement. While a wide variety of bone graft and barrier
membrane products are commercially available, limited evidence exists supporting the use of
one technique over another. The purpose of this study is to radiographically define the
dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR®
(Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of
inflammation, infection, or other wound healing complications.
Participants: A total of 60 patients requiring bone augmentation of a single bound edentulous
site prior to dental implant placement will be selected for this study. This is a multicenter
study with 30 patients receiving treatment at each study site.
Procedures (methods): Patients will be randomly allocated to receive horizontal bone
augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA),
synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. Cone beam computed
tomography (CBCT) imaging will be obtained at baseline and 6 months post-operatively to
assess dimensional alveolar ridge changes. Additionally, post-operative appointments at 1, 2,
and 4 weeks post-grafting will be completed to assess the presence of inflammation,
infection, wound dehiscence, or membrane exposure.
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