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.

Study Overview

• Status: Completed
• Conditions: Chronic Apical Periodontitis of Pulpal Origin
• Intervention / Treatment: Procedure: Endodontic procedure with varied apical preparation size

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • The University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Apical Periodontitis, Root Canal Therapy, Apical Preparation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: 012-1904-342

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No