This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched. Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement. The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
90% bovine derived xenograft granules and 10% porcine collagen
UT Health San Antonio (UTHSA)
San Antonio, Texas, United States
Percent Vital Bone Formation,
shows the amount of new bone formed after the procedure
Time frame: 16 weeks
Percent Residual Graft Material
shows how much of the graft material remained intact
Time frame: 16 weeks
Percent Fibrous Tissue and Marrow Space
amount of tissue that is neither native bone or graft material
Time frame: 16 weeks
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