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Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

NCT02275767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-05-11

Study results available
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Summary

The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Conditions

  • Alveolar Bone Loss

Interventions

DEVICE

50% cortical/50% cancellous FDBA

Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA

DEVICE

100% cortical FDBA

Ridge preservation after tooth extraction using 100% cortical FDBA

DEVICE

100% cancellous FDBA

Ridge preservation after tooth extraction using 100% cancellous FDBA

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Brian L Mealey, DDS, MS · UT Health Science Center at San Antonio, School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275767 on ClinicalTrials.gov