Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft

October 1, 2015 updated by: The University of Texas Health Science Center at San Antonio

Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft

The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center Dental School

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.

Eligibility Criteria

Ages Eligible for Study

19 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single rooted tooth requiring extraction with future dental implant placement

Exclusion Criteria:

  • smoking > 10 cigarettes per day poorly controlled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cancellous FDBA (LifeNet)
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Device: Cancellous FDBA
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Experimental: cortical FDBA (LifeNet)
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Device: cortical FDBA
cortical mineralized freeze-dried bone allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic Percentage of Vital Bone Formation
Time Frame: 18-20 weeks after grafting
Histologic percentage of vital bone formation in bone cores
18-20 weeks after grafting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Brian L Mealey, DDS, MS, The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC20110039H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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