Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
NCT07154693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2026-01-06
Summary
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.
Conditions
- Tooth Extraction
Interventions
- DEVICE
-
Combination 70% FDBA and 30% DFDBA
A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA
- DEVICE
-
OsteoGen Plug
A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)
Sponsors & Collaborators
-
The University of Texas Health Science Center at San Antonio
lead OTHER
Principal Investigators
-
Brian Mealey, DDS, MS · The University of Texas Health Science Center at San Antonio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-19
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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