Healing and bone formation after tooth extraction with OsteoGen ridge preservation
Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)
This will see if a calcium apatite/collagen plug (OsteoGen) produces more new bone than a human bone allograft (70% FDBA/30% DFDBA) in adults having a single non‑molar tooth removed and later replaced with a dental implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT07154693 on ClinicalTrials.gov |
What this trial studies
Adults who need a single non‑molar tooth extracted and plan to receive an implant will have the extraction socket filled with either a calcium apatite/collagen plug (OsteoGen) or a combination allograft (70% FDBA/30% DFDBA). After about 16 weeks of healing, the bone removed during standard implant osteotomy will be collected rather than discarded and analyzed for new bone formation. The amount of new vital bone within the socket will be compared between the two materials to determine which preserves or promotes bone better. Procedures and follow-up visits occur at the University of Texas Health Science Center at San Antonio School of Dentistry.
Who should consider this trial
Good fit: Adults aged 18–89 with a single non‑molar tooth planned for extraction and implant replacement, adequate restorative space and bone height, and a buccal or lingual dehiscence no greater than 50% of the socket depth are ideal candidates.
Not a fit: Patients with molar extractions, large socket defects (>50% depth), insufficient bone height, allergies to bovine collagen or listed antibiotics, or heavy smokers are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the OsteoGen plug could preserve more socket bone so implants fit more predictably and reduce the need for additional grafting procedures.
How similar studies have performed: Previous studies of ridge preservation using allografts and synthetic calcium phosphate materials have generally shown favorable bone preservation, but direct head‑to‑head data for this specific OsteoGen plug versus the specified allograft are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio School of Dentistry — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Brian Mealey, DDS, MS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Brian Mealey, DDS, MS
- Email: mealey@uthscsa.edu
- Phone: 210-567-3589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.