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NCT02387008 · ClinicalTrials.gov registry record · NA
Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT02387008 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 6 participants.
The verdict
NCT02387008, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DEVICE GUIDOR® membrane with FDBA
- DEVICE GUIDOR® membrane
- DEVICE Bio-Gide® membrane with FDBA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2018-11-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02387008
The ClinicalTrials.gov registry entry for NCT02387008 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which GUIDOR® membrane with FDBA is the first listed.
NCT02387008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02387008 about?
NCT02387008 is a clinical study titled "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 anot...
What is the current status of trial NCT02387008?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2017-06-30. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02387008?
The interventions under investigation include: GUIDOR® membrane with FDBA (DEVICE), GUIDOR® membrane (DEVICE), Bio-Gide® membrane with FDBA (DEVICE).
Who is sponsoring clinical trial NCT02387008?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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