Regenerative Endodontic Techniques - Tabular View

Tracking Information

First Received Date ^ICMJE

January 7, 2008

Last Updated Date

March 13, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00595595 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Regenerative Endodontic Techniques

Official Title ^ICMJE

Development of a Model to Evaluate Regenerative Endodontic Techniques

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Cross-Sectional

Condition ^ICMJE

Regenerative Endodontic Tissue Engineering
Dental Pulp Diseases

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1080

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00595595

Responsible Party

Kenneth M. Hargreaves, University of Texas Health Science Center at San Antonio

Study ID Numbers ^ICMJE

HSC20070149H

Study Sponsor ^ICMJE

The University of Texas Health Science Center at San Antonio

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kenneth M Hargreaves, DDS, PhD

University of Texas

Information Provided By

The University of Texas Health Science Center at San Antonio

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP