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20-137-1
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A PILOT RCT STUDY COMPARING DIMENSIONAL ALTERATIONS AFTER SOCKET GRAFTING WITH XENOGRAFT VERSUS ALLOGRAFT
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Dr. Sejal Thacker
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6.1 MASTER LAY SUMMARY STUDY TITLE - A Pilot RCT Study comparing dimensional alterations after socket grafting with xenograft versus allograft BACKGROUND - After extraction of a tooth the healing socket goes through a remodeling process in which there is a substantial dimensional loss of bone volume. Various bone graft materials have been used to minimize this bone volume loss and facilitate future dental implant placement. This study is to test the differences between two bone grafting materials - a xenograft and an allograft. Both grafting materials are extensively and routinely used and are considered standard of care. AIM - The aim of the study is to compare the xenograft and allograft biomaterial when used in extraction sockets to minimize dimensional changes. The comparison between the two materials will be done using a 3-dimensional scan and by doing intraoperative measurements. The performance of the graft will also be compared from a histological standpoint. HYPOTHESIS - The null hypothesis is there is no difference in the performance of the two biomaterials with respect to dimensional changes after 6 months of healing. PRIMARY OBJECTIVE - Horizontal and vertical dimensional changes of extraction sockets as evaluated in a 3 dimensional radiograph (CBCT scan) pre-extraction and 6 months post extraction when grafted with xenograft versus allograft. SECONDARY OBJECTIVE - Horizontal and vertical dimensional changes of extraction sockets as evaluated intraoperatively in patients mouth pre-extraction and 6 months post extraction when grafted with xenograft versus allograft. Histological difference in the healing of the graft particles. A biopsy of the site will be done at 6 months and the core will be used for histological analysis Amount of newly regenerated bone will be evaluated using a micro CT analysis. The biopsy cores used for histology will be used for this purpose as well.
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Dental, Including Mouth
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Check with study contact
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Megyn Clement. Telephone: 860-679-4995. Email: mclement@uchc.edu
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This study is closed to enrollment and completed data analysis.
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