Comparing two types of bone grafts for tooth replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.