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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01588444
First received: March 16, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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, residual graft material and CT/other [ Time Frame: 18-20 weeks after grafting ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588444     History of Changes
Other Study ID Numbers: HSC20110039H
Study First Received: March 16, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013