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

NCT06722482 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00008216AWD00006192
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean change in radiographic horizontal and vertical ridge dimensions

  Linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes will be measured and compared between groups after 16 weeks of healing.

  baseline to 16 weeks after surgery

Secondary Outcomes (15)

• Mean change in alveolar ridge contour

  baseline to 4 weeks after surgery

• Mean change in alveolar ridge contour

  baseline to 2 months after implant placement, approximately 24 weeks

• Mean change in alveolar ridge contour

  baseline to 12 months after implant placement, approximately 70 weeks

• Number of implants/participants with an implant placed on a prosthetically driven position

  16 weeks

• Mean percentage of residual bone graft particles

  16 weeks

Study Arms (2)

FDBA arm

EXPERIMENTAL

Device: FDBA

CEBX arm

ACTIVE COMPARATOR

Device: CEBX

Interventions

FDBA DEVICE

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

Also known as: Freeze-dried bone allograft

FDBA arm

CEBX DEVICE

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

Also known as: Collagen-enriched bovine xenograft

CEBX arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Implant Dentistry Research & Education Foundation (IDREF): collaborator

Study Sites (1)

Eastman Institute for Oral Health

Rochester, New York, 14620, United States

RECRUITING

Study Officials

• Elli Anna Kotsailidi, DDS, MS

  Eastman Institute for Oral Health, University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elli Anna Kotsailidi, DDS, MS

CONTACT

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

Nasser Assery, BDS, MS

CONTACT

nasser_assery@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded in regards to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: single center, pilot, randomized, clinical trial

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: November 27, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)