NCT02387008

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bone Regeneration

Interventions

Type	Name	Description
DEVICE	GUIDOR® membrane with FDBA	horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
DEVICE	GUIDOR® membrane	horizontal bone augmentation with synthetic GUIDOR® membrane
DEVICE	Bio-Gide® membrane with FDBA	xenograft BioGide® membrane + FDBA

Timeline

• Start date: 2017-06-30
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2015-03-12
• Last updated: 2019-09-25
• Results posted: 2019-06-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study