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Longitudinal Endodontic Study of Apical Preparation Size
This study has been completed.
Study NCT00223379   Information provided by The University of Texas Health Science Center at San Antonio
First Received: September 13, 2005   Last Updated: July 18, 2008   History of Changes

September 13, 2005
July 18, 2008
December 2002
December 2007   (final data collection date for primary outcome measure)
Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.
Complete list of historical versions of study NCT00223379 on ClinicalTrials.gov Archive Site
Pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Pain
 
Longitudinal Endodontic Study of Apical Preparation Size
Longitudinal Endodontic Study of Apical Preparation Size

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.

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 (i.e., 0.2 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

 
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Chronic Apical Periodontitis of Pulpal Origin
Procedure: Endodontic procedure with varied apical preparation size
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
36
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient must be at least 18 years of age.
  2. Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
  3. 1st or 2nd maxillary or mandibular molar.
  4. Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
  5. Intact, mature apices.
  6. ASA I or II.

Exclusion Criteria:

  1. Failure to meet any of the above
  2. Previous NSRCT
  3. Previous pulpotomy or pulpectomy
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223379
Kenneth Hargreaves, DDS, PhD, University of Texas Health Science Center San Antonio
012-1904-342
The University of Texas Health Science Center at San Antonio
 
Principal Investigator: Karl Keiser, DDS, MS The University of Texas Health Science Center at San Antonio, Texas
The University of Texas Health Science Center at San Antonio
July 2008

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