Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Extraction
• Intervention / Treatment: Device: OsteoGen Plug; Device: Combination 70% FDBA and 30% DFDBA

Detailed Description

At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.

This will be done by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.

At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.

The study team will do this by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Mealey, DDS, MS; Phone Number: 210-567-3589; Email: mealey@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio School of Dentistry
      • Contact: Brian L Mealey, DDS, MS; Phone Number: 210-567-3318; Email: mealey@uthscsa.edu
      • Principal Investigator: Brian L. Mealey, DDS, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
• Site has a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and nonpregnant women of child-bearing potential.
• Patients are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day)

Exclusion Criteria:

• 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).

  • Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
• Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Osteogen Test Group; A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®	Device: OsteoGen Plug; A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product); Other Names: Osteogen
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®	Device: Combination 70% FDBA and 30% DFDBA; A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA; Other Names: FDBA/DFDBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Vital Bone formation	Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Residual Graft Material	Determine percentage of residual graft remaining at time of implant placement	16 weeks
Percentage of CT/other	Determine the percentage of residual graft and connective tissue or other tissue at the time of implant placement	16 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Brian Mealey, DDS, MS, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Wound healing; Ridge preservation; Vital bone; Mineralized freeze-dried bone allograft (FDBA); Demineralized freeze-dried bone allograft (DFDBA)
• Other Study ID Numbers: STUDY00001531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be thoroughly de-identified and will not be traceable to a specific study participant. If the results of this study are reported in medical journals or at meetings, you will not be identified.
• IPD Sharing Time Frame: The investigators plan to publish the data once the study is complete and data analysis has occurred. Summary results will also be reported on ClinicalTrials.gov at least one year after primary completion date is reached.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No