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Longitudinal Endodontic Study of Apical Preparation Size

This study has been completed.
Information provided by The University of Texas Health Science Center at San Antonio

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Descriptive Information Fields
Brief Title  Longitudinal Endodontic Study of Apical Preparation Size
Official Title  Longitudinal Endodontic Study of Apical Preparation Size
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 (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

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
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 ]
Secondary Outcome Measure  Pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Condition  Chronic Apical Periodontitis of Pulpal Origin
Intervention  Procedure: Endodontic procedure with varied apical preparation size
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  36
Start Date  December 2002
Completion Date December 2007
Eligibility 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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00223379
Organization ID 012-1904-342
Secondary IDs ††
Study Sponsor  The University of Texas Health Science Center at San Antonio
Collaborators ††
Investigators 
Principal Investigator:     Karl Keiser, DDS, MS     The University of Texas Health Science Center at San Antonio, Texas    
Information Provided By The University of Texas Health Science Center at San Antonio
Verification Date July 2008
First Received Date  September 13, 2005
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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