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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


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
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