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Longitudinal Endodontic Study of Apical Preparation Size

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ClinicalTrials.gov Identifier: NCT00223379
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Chronic Apical Periodontitis of Pulpal Origin Procedure: Endodontic procedure with varied apical preparation size Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Longitudinal Endodontic Study of Apical Preparation Size
Study Start Date : December 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Intervention Details:
  • Procedure: Endodontic procedure with varied apical preparation size
    Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method


Primary Outcome Measures :
  1. Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin. [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223379


Locations
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United States, Texas
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Karl Keiser, DDS, MS The University of Texas Health Science Center at San Antonio, Texas
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Responsible Party: Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223379    
Other Study ID Numbers: 012-1904-342
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio:
Apical Periodontitis, Root Canal Therapy, Apical Preparation
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases