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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. |
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| 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 |
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| 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:
Exclusion Criteria:
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| 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 † |
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| 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 | ||||