RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.

Quick Facts

Study Start:2023-11-27
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06722482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients able to provide informed consent
  2. * patients of 18 years of age or older at time of consent and enrollment
  3. * patients in need of at least one anterior tooth extraction and seeking dental implant replacement
  4. * 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)
  1. * current smokers or tobacco-product users (self-reported)
  2. * uncontrolled diabetes (HbA1c≥7 in the last 3 months)
  3. * pregnant and/or lactating females (self-reported)
  4. * 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
  5. * patients with history of radiation of the head and neck
  6. * patients with allergy to collagen, bacitracin and/or polymyxin B
  7. * patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material
  8. * patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves
  9. * patients with untreated periodontitis
  10. * patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area
  11. * patients with central/lateral incisors or canines with buccal bone dehiscence \>5mm

Contacts and Locations

Study Contact

Elli Anna Kotsailidi, DDS, MS
CONTACT
585-274-1146
elli_kotsailidi@urmc.rochester.edu
Nasser Assery, BDS, MS
CONTACT
nasser_assery@urmc.rochester.edu

Principal Investigator

Elli Anna Kotsailidi, DDS, MS
PRINCIPAL_INVESTIGATOR
Eastman Institute for Oral Health, University of Rochester

Study Locations (Sites)

Eastman Institute for Oral Health
Rochester, New York, 14620
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Elli Anna Kotsailidi, DDS, MS, PRINCIPAL_INVESTIGATOR, Eastman Institute for Oral Health, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

  • alveolar ridge preservation
  • tooth extraction
  • freeze-dried bone allograft
  • collagen-enriched bovine xenograft

Additional Relevant MeSH Terms

  • Ridge Preservation
  • Allografts
  • Extraction, Tooth
  • Xenograft