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Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant

RecruitingNAAges 18 Years - anyAllUniversity of Rochester
NCT06722482 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material. The study aims to examine the following main questions: * Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing * Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated. The

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📋 Eligibility rules (as published)
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
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What it tests

  • FDBA
  • CEBX
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Where

1 site
Eastman Institute for Oral Health
Rochester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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