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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01588444
Other study ID # HSC20110039H
Secondary ID
Status Completed
Phase N/A
First received March 16, 2012
Last updated October 1, 2015
Start date October 2010
Est. completion date July 2012

Study information

Verified date October 2015
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 99 Years
Eligibility Inclusion Criteria:

- single rooted tooth requiring extraction with future dental implant placement

Exclusion Criteria:

- smoking > 10 cigarettes per day poorly controlled diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
cortical FDBA
cortical mineralized freeze-dried bone allograft
Cancellous FDBA
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)

Locations

Country Name City State
United States UT Health Science Center Dental School San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Histologic Percentage of Vital Bone Formation Histologic percentage of vital bone formation in bone cores 18-20 weeks after grafting No
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