Comparing two types of bone grafts for tooth replacement
Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
NA · University of Rochester · NCT06722482
This study is testing which of two types of bone grafts helps people keep their jawbone healthy after losing a front tooth before getting a dental implant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06722482 on ClinicalTrials.gov |
What this trial studies
This study compares two bone graft materials, freeze-dried bone allograft (FDBA) and collagen-enriched bovine xenograft (CEBX), used for preserving bone after the extraction of an anterior tooth before dental implant placement. Patients will be randomly assigned to receive either FDBA or CEBX, and the study will evaluate differences in ridge dimensional changes, clinical outcomes, and patient satisfaction over a 16-week healing period. The study includes multiple visits and utilizes advanced imaging techniques to assess the effectiveness of each graft material.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require extraction of an anterior tooth and seek dental implant replacement.
Not a fit: Patients who smoke, have uncontrolled diabetes, or are on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the outcomes of dental implant procedures by identifying the more effective bone graft material.
How similar studies have performed: Previous studies have shown varying success with different bone graft materials, making this a relevant comparison in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients able to provide informed consent * patients of 18 years of age or older at time of consent and enrollment * patients in need of at least one anterior tooth extraction and seeking dental implant replacement * bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence \</=5mm as determined radiographically through cone beam computed tomography (CBCT) Exclusion Criteria: * current smokers or tobacco-product users (self-reported) * uncontrolled diabetes (HbA1c≥7 in the last 3 months) * pregnant and/or lactating females (self-reported) * patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update * patients with history of radiation of the head and neck * patients with allergy to collagen, bacitracin and/or polymyxin B * patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material * patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves * patients with untreated periodontitis * patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area * patients with central/lateral incisors or canines with buccal bone dehiscence \>5mm
Where this trial is running
Rochester, New York
- Eastman Institute for Oral Health — Rochester, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Elli Anna Kotsailidi, DDS, MS — Eastman Institute for Oral Health, University of Rochester
- Study coordinator: Elli Anna Kotsailidi, DDS, MS
- Email: elli_kotsailidi@urmc.rochester.edu
- Phone: 585-274-1146
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.
Conditions: Ridge Preservation, Allografts, Extraction, Tooth, Xenograft, alveolar ridge preservation, tooth extraction, freeze-dried bone allograft, collagen-enriched bovine xenograft