Clinical Trial: Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

Brief 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.


Detailed Summary:

The study is 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 study is a 3-arm, parallel-design, randomized, prospective clinical trial. 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.


Sponsor: The University of Texas Health Science Center at San Antonio

Current Primary Outcome: % Vital Bone Formation (Histological) [ Time Frame: 18-20 weeks after ridge preservation ]

histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery


Original Primary Outcome: Same as current

Current Secondary Outcome: % Residual Graft Material (Histological) [ Time Frame: 18-20 weeks after ridge preservation ]

histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery


Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center at San Antonio

Dates:
Date Received: October 22, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 6, 2016
Last Verified: April 2016