Accuracy of ERCLMDs in Teeth With Apical Periodontitis (ERCLMDs)

July 17, 2013 updated by: Masoud Saatchi, Isfahan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apical periodontitis (AP)
clinical pulp necrosis periapical index scores of 3, 4 or 5
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
Other Names:
  • Dentaport ZX
  • Raypex
  • i-Root
Experimental: normal periapex (NP)
clinical pulp vitality periapical index score of 1
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
Other Names:
  • Dentaport ZX
  • Raypex
  • i-Root

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Actual working length (AWL)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Electronic working length (EWL)
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
working length
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Masoud Saatchi, DDS MS, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grant: 390553 (Other Identifier: Isfahan University of Medical Sciences)
  • 39232 (Other Identifier: Isfahan University of Medical Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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