Longitudinal Endodontic Study of Apical Preparation Size

NCT ID: NCT00223379

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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

Conditions

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Chronic Apical Periodontitis of Pulpal Origin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Endodontic procedure with varied apical preparation size

Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Hargreaves

Chair, Dept. of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Keiser, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio, Texas

Locations

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The University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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012-1904-342

Identifier Type: -

Identifier Source: org_study_id

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