Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedOctober 22, 2015
October 1, 2015
1.8 years
March 16, 2012
October 1, 2014
October 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histologic Percentage of Vital Bone Formation
Histologic percentage of vital bone formation in bone cores
18-20 weeks after grafting
Study Arms (2)
cancellous FDBA (LifeNet)
EXPERIMENTALgrafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
cortical FDBA (LifeNet)
EXPERIMENTALCORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Interventions
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Eligibility Criteria
You may qualify if:
- single rooted tooth requiring extraction with future dental implant placement
You may not qualify if:
- smoking \> 10 cigarettes per day poorly controlled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health Science Center Dental School
San Antonio, Texas, 78229, United States
Related Publications (1)
Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31.
PMID: 23725026DERIVED
Results Point of Contact
- Title
- Dr. Brian Mealey
- Organization
- UT Health Sci Ctr San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Brian L Mealey, DDS, MS
The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2012
First Posted
May 1, 2012
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 22, 2015
Results First Posted
October 6, 2014
Record last verified: 2015-10