Longitudinal Endodontic Study of Apical Preparation Size

Chronic Apical Periodontitis of Pulpal Origin Clinical Trial

Official title:

Longitudinal Endodontic Study of Apical Preparation Size

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223379
• Other study ID #: 012-1904-342
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 6, 2012
• Start date: December 2002
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Apical Periodontitis of Pulpal Origin
• Periapical Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic and clinical evidence of osseous healing of chronic apical periodontitis of pulpal origin.		2 year	No
Secondary	Pain		2 years	No