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NCT02515058 · ClinicalTrials.gov registry record · NA
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02515058 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 44 participants.
The verdict
NCT02515058, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 PUROS (Ridge Preservation bone grafting surgery)
- DEVICE FDBA (Ridge Preservation bone grafting surgery)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02515058
The ClinicalTrials.gov registry entry for NCT02515058 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 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 2 interventions - of which PUROS (Ridge Preservation bone grafting surgery) is the first listed.
NCT02515058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02515058 about?
NCT02515058 is a clinical study titled "Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts". The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire protocol involves procedur...
What is the current status of trial NCT02515058?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2015-09. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02515058?
The interventions under investigation include: PUROS (Ridge Preservation bone grafting surgery) (DEVICE), FDBA (Ridge Preservation bone grafting surgery) (DEVICE).
Who is sponsoring clinical trial NCT02515058?
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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