Clinical Trial: Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Brief Summary:

The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This 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 porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. 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 bovine xenograft and porcine xenograft materials.

This entire protocol involves procedures that are standard care. The study is a 2-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

In keeping with the protocol our study group has used several times before, the plan will be to extract non-molar teeth and graft with the test/control materials. Each subject will provide a single non-molar tooth site for study treatment. The graft material will be covered with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles, Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the 4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is placed. This osteotomy can be prepared with either a solid drill, in which case the bone that is removed is suctioned into the suction system, or with a hollow trephine drill into which a core of bone can be collected. The only "research procedure" being done in the current study is the collection of this bone core biopsy for histologic evaluation. 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: % residual graft material (histological) [ Time Frame: 18-20 weeks after ridge preservation ]

Original Secondary Outcome: Same as current

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

Dates:
Date Received: June 13, 2016
Date Started: July 2016
Date Completion: October 2018
Last Updated: January 9, 2017
Last Verified: January 2017