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NCT02275767 · ClinicalTrials.gov registry record · NA
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT02275767 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 66 participants.
The verdict
NCT02275767, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
Study Summary
The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Interventions
- DEVICE 50% cortical/50% cancellous FDBA
- DEVICE 100% cortical FDBA
- DEVICE 100% cancellous FDBA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02275767
The ClinicalTrials.gov registry entry for NCT02275767 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 50% cortical/50% cancellous FDBA is the first listed.
NCT02275767 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02275767 about?
NCT02275767 is a clinical study titled "Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft". The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol invo...
What is the current status of trial NCT02275767?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2014-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02275767?
The interventions under investigation include: 50% cortical/50% cancellous FDBA (DEVICE), 100% cortical FDBA (DEVICE), 100% cancellous FDBA (DEVICE).
Who is sponsoring clinical trial NCT02275767?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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