Viewing Study NCT00223379



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Study NCT ID: NCT00223379
Status: COMPLETED
Last Update Posted: 2012-03-08
First Post: 2005-09-13

Brief Title: Longitudinal Endodontic Study of Apical Preparation Size
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: Longitudinal Endodontic Study of Apical Preparation Size
Status: COMPLETED
Status Verified Date: 2012-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This protocol is for a clinical trial evaluating the clinical success of root canal therapy performed on teeth with chronic apical periodontitis of pulpal origin with either large or small apical root canal preparation techniques
Detailed Description: This randomized clinical trial will compare the clinical success of two commonly used techniques for performing non-surgical endodontic procedures on teeth with chronic apical periodontitis of pulpal origin The first method termed the GT method uses a commercially available rotary file system to instrument the root canal systems from the crown to the apical portion of the root After completion of this technique the apical portion of the root is prepared to the same standardized ISO size 20 in all roots ie 02 mm cross-sectional diameter The second method termed the Lightspeed method uses a different commercially available rotary file system to shape the root canal systems from the apical to the crown portion of the root After completion of this technique the apical preparation is often larger in cross-sectional diameter than that observed after the GT method however an equally important distinction is that the Lightspeed method customizes the final cross-sectional diameter for each root canal system and thus each root has a similar enlargement of apical preparation size due to proportionate removal of infected dentin at the end of the root Although the Lightspeed method may result in reduced bacteria in the apical portion of root canal systems there is no evidence to date that this effect improves clinical success rates This study will test the hypothesis that the larger apical preparation size produced by the Lightspeed instrumentation system will produce a higher percentage of clinically successful treatments of teeth with apical periodontitis AP as compared to the GT method

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None