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Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space

Bone Regeneration Clinical Trial

Official title:
Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02387008
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Terminated
Phase N/A
Start date June 30, 2017
Completion date November 28, 2018
View Details
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