Longitudinal Endodontic Study of Apical Preparation Size - Full Text View

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

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 ]

Enrollment:	36
Study Start Date:	December 2002
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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

Contacts and Locations

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

Locations

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

Principal Investigator:

Karl Keiser, DDS, MS

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

More Information

No publications provided

Responsible Party:	University of Texas Health Science Center San Antonio ( Kenneth Hargreaves, DDS, PhD )
Study ID Numbers:	012-1904-342
Study First Received:	September 13, 2005
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00223379 History of Changes
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
Stomatognathic Diseases
Periapical Periodontitis

Additional relevant MeSH terms:

Mouth Diseases
Periodontal Diseases
Periodontitis
Periapical Diseases

Jaw Diseases
Stomatognathic Diseases
Periapical Periodontitis

ClinicalTrials.gov processed this record on July 06, 2009