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Accuracy of ERCLMDs in Teeth With Apical Periodontitis (ERCLMDs)

Primary Purpose

Apical Periodontitis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Electronic Root Canal Length Measurement Device

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Apical periodontitis, Dentaport ZX, electronic apex locators, i-Root, Raypex 5, working length

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

apical periodontitis (AP)

normal periapex (NP)

Arm Description

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

clinical pulp vitality periapical index score of 1

Outcomes

Primary Outcome Measures

Actual working length (AWL)

Secondary Outcome Measures

Electronic working length (EWL)

Full Information

NCT ID

NCT01904552

First Posted

July 11, 2013

Last Updated

July 17, 2013

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01904552

Brief Title

Accuracy of ERCLMDs in Teeth With Apical Periodontitis

Acronym

ERCLMDs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apical Periodontitis

Keywords

Apical periodontitis, Dentaport ZX, electronic apex locators, i-Root, Raypex 5, working length

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

apical periodontitis (AP)

Arm Type

Experimental

Arm Description

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

Arm Title

normal periapex (NP)

Arm Type

Experimental

Arm Description

clinical pulp vitality periapical index score of 1

Intervention Type

Device

Intervention Name(s)

Electronic Root Canal Length Measurement Device

Other Intervention Name(s)

Dentaport ZX, Raypex, i-Root

Intervention Description

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

Primary Outcome Measure Information:

Title

Actual working length (AWL)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Electronic working length (EWL)

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

working length

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masoud Saatchi, DDS MS

Organizational Affiliation

Isfahan University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Isfahan University of Medical Sciences

City

Isfahan

ZIP/Postal Code

81746-73461

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://mui.ac.ir/en/

Description

Isfahan University of Medical Sciences

Learn more about this trial

Accuracy of ERCLMDs in Teeth With Apical Periodontitis

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