Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07154693
Status
Recruiting
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Conditions

  • Tooth Extraction

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
Nov 19, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Osteogen Test Group
    A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®
  • Active Comparator: FDBA/DFDBA Control Group
    A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Primary Outcome Measure

Percentage of Vital Bone formation [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San Antonio School of DentistrySan AntonioTexas78229
Brian L Mealey, DDS, MS
[email protected]
210-567-3318
Brian L. Mealey, DDS, MS (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Health Science Center at San Antonio School of Dentistry· San Antonio, TX

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