ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Longitudinal Endodontic Study of Apical Preparation Size

This study is currently recruiting participants.
Verified by The University of Texas Health Science Center at San Antonio, December 2007

Sponsored by: The University of Texas Health Science Center at San Antonio
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223379
  Purpose

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 Intervention
Chronic Apical Periodontitis of Pulpal Origin
Procedure: Endodontic procedure with varied apical preparation size

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:   Longitudinal Endodontic Study of Apical Preparation Size

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   36
Study Start Date:   December 2002
Estimated 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
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

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223379

Contacts
Contact: Karl Keiser, DDS, MS     210-567-3381     Keiser@uthscsa.edu    
Contact: Erin Locke, RN, BSN     210-567-0895     Locke@uthscsa.edu    

Locations
United States, Texas
The University of Texas Health Science Center     Recruiting
      San Antonio, Texas, United States, 78229-3900
      Contact: Karl Keiser, DDS, MS     210-567-3381     Keiser@uthscsa.edu    
      Contact: Erin Locke, RN, BSN     210-567-0895     Locke@uthscsa.edu    
      Principal Investigator: Karl Keiser, DDS, MS            
      Sub-Investigator: Kenneth M. Hargreaves, DDS, PhD            

Sponsors and Collaborators
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    
  More Information

Responsible Party:   University of Texas Health Science Center San Antonio ( Kenneth Hargreaves, DDS, PhD )
Study ID Numbers:   012-1904-342
First Received:   September 13, 2005
Last Updated:   December 15, 2007
ClinicalTrials.gov Identifier:   NCT00223379
Health Authority:   United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Apical Periodontitis, Root Canal Therapy, Apical Preparation  

Study placed in the following topic categories:
Mouth Diseases
Periodontal Diseases
Periodontitis
Periapical Diseases
Periapical Periodontitis

Additional relevant MeSH terms:
Jaw Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 03, 2008




Links to all studies - primarily for crawlers