Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorThe University of Texas Health Science Center at San Antonio

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Combination 70% FDBA and 30% DFDBA

    Device

    A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA

  • OsteoGen Plug

    Device

    A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Osteogen Test GroupActive comparator 1 intervention
Group B: FDBA/DFDBA Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Vital Bone formation

Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation

Time frame
16 weeks

Secondary outcomes

1

Percentage of Residual Graft Material

Determine percentage of residual graft remaining at time of implant placement

Time frame
16 weeks
2

Percentage of CT/other

Determine the percentage of residual graft and connective tissue or other tissue at the time of implant placement

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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