The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
102
Demineralized freeze-dried bone allograft (DFBA) in a small particle form
A combination of cow-derived xenograft and human-derived DFDBA particulate
Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
University of Texas Health Science Center at San Antonio (Dental School)
San Antonio, Texas, United States
Percentage Vital Bone Formation
Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.
Time frame: Wound healing time ( approximately 18 to 20 weeks)
Percentage of Residual Graft Material
Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery.
Time frame: Wound healing time ( approximately 18 to 20 weeks)
Percentage of Connective Tissue at Time of Implant
Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery.
Time frame: Baseline to 18-20 weeks
Change in Ridge Width (Clinical Measurement)
Measure of change in ridge width from extraction to healing time
Time frame: Baseline to 18-20 weeks
Change in Buccal Ridge Height (Clinical Measurement)
Measure of change in buccal ridge height from extraction to healing time
Time frame: Baseline to 18-20 weeks
Change in Lingual Ridge Height (Clinical Measurement)
Measure of change in lingual ridge height from extraction to healing time
Time frame: Baseline to 18-20 weeks
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A combination of cow-derived xenograft and human-derived DFDBA fibers