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Longitudinal Endodontic Study of Apical Preparation Size

This study is currently recruiting patients

Verified by The University of Texas Health Science Center at San Antonio September 2006

Sponsored by: UT Health Science Center at San Antonio
Information provided by: UT Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223379


Purpose

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.


Condition Intervention
Chronic Apical Periodontitis of Pulpal Origin Procedure: Endodontic procedure with varied apical preparation size

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Official Title: Longitudinal Endodontic Study of Apical Preparation Size

Further study details as provided by The University of Texas Health Science Center at San Antonio:
Primary Outcomes: Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.
Secondary Outcomes: Pain
Expected Total Enrollment:  733

Study start: December 2002

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

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00223379

Karl Keiser, DDS, MS      210-567-3381    Keiser@uthscsa.edu
Erin Locke, RN, BSN      210-567-0895    Locke@uthscsa.edu

Texas
The University of Texas Health Science Center, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Karl Keiser, DDS, MS  210-567-3381    Keiser@uthscsa.edu 
Erin Locke, RN, BSN  210-567-0895    Locke@uthscsa.edu 
Karl Keiser, DDS, MS,  Principal Investigator
Kenneth M. Hargreaves, DDS, PhD,  Sub-Investigator

Study chairs or principal investigators

Karl Keiser, DDS, MS,  Principal Investigator,  The University of Texas Health Science Center at San Antonio, Texas   

More Information

Study ID Numbers:  012-1904-342
Last Updated:  September 25, 2006
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00223379
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-09-29





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