Longitudinal Endodontic Study of Apical Preparation Size
Primary Purpose
Chronic Apical Periodontitis of Pulpal Origin
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endodontic procedure with varied apical preparation size
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Apical Periodontitis of Pulpal Origin focused on measuring Apical Periodontitis, Root Canal Therapy, Apical Preparation
Eligibility Criteria
Inclusion Criteria: Patient must be at least 18 years of age. Clinical indication for Non-Surgical Root Canal Therapy (NSRCT). 1st or 2nd maxillary or mandibular molar. Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms. Intact, mature apices. ASA I or II. Exclusion Criteria: Failure to meet any of the above Previous NSRCT Previous pulpotomy or pulpectomy
Sites / Locations
- The University of Texas Health Science Center
Outcomes
Primary Outcome Measures
Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.
Secondary Outcome Measures
Pain
Full Information
NCT ID
NCT00223379
First Posted
September 13, 2005
Last Updated
March 6, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00223379
Brief Title
Longitudinal Endodontic Study of Apical Preparation Size
Official Title
Longitudinal Endodontic Study of Apical Preparation Size
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Apical Periodontitis of Pulpal Origin
Keywords
Apical Periodontitis, Root Canal Therapy, Apical Preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Endodontic procedure with varied apical preparation size
Intervention Description
Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method
Primary Outcome Measure Information:
Title
Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Pain
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient must be at least 18 years of age.
Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
1st or 2nd maxillary or mandibular molar.
Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
Intact, mature apices.
ASA I or II.
Exclusion Criteria:
Failure to meet any of the above
Previous NSRCT
Previous pulpotomy or pulpectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Keiser, DDS, MS
Organizational Affiliation
The University of Texas Health Science Center at San Antonio, Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
12. IPD Sharing Statement
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Longitudinal Endodontic Study of Apical Preparation Size
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