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NCT Number: NCT07154693

Wound Healing Following Tooth Extraction and Ridge Preservation Using 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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio School of Dentistry

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Brian L Mealey, DDS, MS

CONTACT

[email protected]

210-567-3318

Brian L. Mealey, DDS, MS

PRINCIPAL_INVESTIGATOR

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Combination 70% FDBA and 30% DFDBA

Device

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

Other names: FDBA/DFDBA

OsteoGen Plug

Device

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

Other names: Osteogen

Primary outcomes

  1. Percentage of Vital Bone formation

    Time frame: 16 weeks

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

Secondary outcomes

  1. Percentage of Residual Graft Material

    Time frame: 16 weeks

    Determine percentage of residual graft remaining at time of implant placement

  2. Percentage of CT/other

    Time frame: 16 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Mealey, DDS, MS

CONTACT

[email protected]

210-567-3589

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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