Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

The University of Texas System (UT)

Status: Enrolling

Conditions: Tooth Extraction

Treatments: Device: Combination 70% FDBA and 30% DFDBA; Device: OsteoGen Plug

Study type: Interventional

Funder types: Other

Identifiers

NCT07154693

STUDY00001531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Osteogen Test Group

Active Comparator group

Description:

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Treatment:

Device: OsteoGen Plug

FDBA/DFDBA Control Group

Active Comparator group

Description:

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Treatment:

Device: Combination 70% FDBA and 30% DFDBA