Accuracy of ERCLMDs in Teeth With Apical Periodontitis

Apical Periodontitis Clinical Trial

— ERCLMDs  

Official title:

Influence of Apical Periodontitis on the Accuracy of Three Electronic Root Canal Length Measurement Devices: An In Vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904552
• Other study ID #: Grant: 390553
• Secondary ID: Grant: 390553392
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2013
• Last updated: July 17, 2013
• Start date: September 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement devices.

Description:

Thirty-two single-rooted teeth scheduled for extraction, consisting of 16 teeth with AP and 16 teeth with normal periapex (NP), were selected. Access cavity was prepared and coronal portion of the canal was flared. Electronic working length (EWL) was determined by each ERCLMD according to each manufacturer's instructions. Each tooth was extracted and actual working length (AWL) was determined by inserting a size 15 K-file until the tip could be seen at a position tangential to the major foramen and then 0.5 mm was subtracted from the measurement. The distance from the AWL to the file tip was calculated and compared between the two groups by t-test. The accuracy of each ERCLMD within ±0.5 mm was compared between the groups by Fisher's test. Statistical significance was set at P < .05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• single-rooted teeth

• clinical pulp necrosis and periapical index scores of 3, 4 or 5

• pulp vitality and a periapical index score of 1

Exclusion Criteria:

• Teeth with metal restorations

• Teeth with prosthetic crowns

• Teeth with pulp calcification

• Teeth with previous endodontic treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Device:
• Electronic Root Canal Length Measurement Device
Electronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	working length		6 months	Yes
Primary	Actual working length (AWL)		6 months	Yes
Secondary	Electronic working length (EWL)		6 months	Yes

External Links

•   Isfahan University of Medical Sciences