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Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00595595
First Posted: January 16, 2008
Last Update Posted: September 17, 2012
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):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
  Purpose
Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.

Condition
Dental Pulp Regeneration Dental Pulp Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Development of a Model to Evaluate Regenerative Endodontic Techniques

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

Biospecimen Retention:   Samples With DNA
extracted teeth 10ml of blood for DNA banking

Enrollment: 1080
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:
The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for surgical removal of impacted teeth
Criteria

Inclusion Criteria:

  • Pre-existing indication for surgical extraction of impacted teeth
  • Age 16-65

Exclusion Criteria:

  • Ages less than 16 or over 65
  • No pre-existing indication for surgical extraction of impacted teeth
  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): NCT00595595


Locations
United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Kenneth M Hargreaves, DDS, PhD The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00595595     History of Changes
Other Study ID Numbers: HSC20070149H
First Submitted: January 7, 2008
First Posted: January 16, 2008
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio:
Dental Pulp
Regenerative Medicine
Odontoblasts
Stem Cells
Growth factor differentiation of stem/progenitor cells
Odontoblast-specific cell phenotypes

Additional relevant MeSH terms:
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases