Recruiting

Bone Grafts

Sponsor:

University of Rochester

Code:

NCT06722482

Conditions

Ridge Preservation

Allografts

Extraction, Tooth

Xenograft

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FDBA

CEBX

Study Details

Brief summary:

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.

Conditions

Ridge Preservation

Allografts

Extraction, Tooth

Xenograft

Study ID

NCT06722482

Start date

Nov 27, 2023

Status verified date

Jan, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FDBA arm

active comparator: CEBX arm

Interventions

FDBA

Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.

CEBX

Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.

Primary outcome measure

  • Mean change in radiographic horizontal and vertical ridge dimensions [ Time Frame: baseline to 16 weeks after surgery ]

Central Contacts and Locations

Central contacts

Elli Anna Kotsailidi, DDS, MS

585-274-1146elli_kotsailidi@urmc.rochester.edu

Nasser Assery, BDS, MS

nasser_assery@urmc.rochester.edu

Locations

Eastman Institute for Oral Health

Recruiting

Rochester, New York, United States, 14620

Contacts

Elli Anna Kotsailidi, DDS, MS

5856429948elli_kotsailidi@urmc.rochester.edu

Nasser Assery, BDS, MS

nasser_assery@umc.rochester.edu

Principal Investigator:

Elli Anna Kotsailidi, DDS, MS

More Information

Sponsor

University of Rochester

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-01-09.