About this trial
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved.
This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female patient aged 18 to 89
One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
A dental implant is indicated and treatment planned to replace the missing tooth
Site has adequate restorative space for a dental implant-retained restoration
Disqualifiers
Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
Patients who will not cooperate with the follow-up schedule.
Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
Trial design
Parallel
Treatments tested in this trial
Combination 70% FDBA and 30% DFDBA
DeviceA combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA
OsteoGen Plug
DeviceA synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Vital Bone formation
Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation
Secondary outcomes
Percentage of Residual Graft Material
Determine percentage of residual graft remaining at time of implant placement
Percentage of CT/other
Determine the percentage of residual graft and connective tissue or other tissue at the time of implant placement
Sponsors and contacts
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