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OpenTrials
Completed

NCT Number: NCT00223379

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endodontic procedure with varied apical preparation size

Procedure

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

Primary outcomes

  1. Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.

    Time frame: 2 year

Secondary outcomes

  1. Pain

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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