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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06722482
Status
Recruiting

Conditions

  • Allografts
  • Extraction, Tooth
  • Ridge Preservation
  • Xenograft

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Jan 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FDBA arm
  • Active Comparator: CEBX arm

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eastman Institute for Oral HealthRochesterNew York14620
Elli Anna Kotsailidi, DDS, MS
5856429948
Nasser Assery, BDS, MS
Elli Anna Kotsailidi, DDS, MS (PRINCIPAL_INVESTIGATOR)
Alexandra Tsigarida, DDS, MS (SUB_INVESTIGATOR)
Nasser Assery, BDS, MS (SUB_INVESTIGATOR)
Hongyue Cookie Wang, PhD (SUB_INVESTIGATOR)

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