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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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 study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:

* Demographic information * Clinical information from intraoral photographs * Radiographic information from cone beam computed tomography and periapical radiographs.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FDBA
  • CEBX

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Rochester

Lead sponsor

Implant Dentistry Research & Education Foundation (IDREF)

Collaborator