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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588444
First Posted: May 1, 2012
Last Update Posted: October 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
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.

Condition Intervention
Tooth Extraction Device: cortical FDBA Device: Cancellous FDBA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Histologic Percentage of Vital Bone Formation [ Time Frame: 18-20 weeks after grafting ]
    Histologic percentage of vital bone formation in bone cores


Enrollment: 40
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single rooted tooth requiring extraction with future dental implant placement

Exclusion Criteria:

  • smoking > 10 cigarettes per day poorly controlled diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588444


Locations
United States, Texas
UT Health Science Center Dental School
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588444     History of Changes
Other Study ID Numbers: HSC20110039H
First Submitted: March 16, 2012
First Posted: May 1, 2012
Results First Submitted: October 1, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by The University of Texas Health Science Center at San Antonio:
tooth extraction
bone grafting