NCT01904552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

July 11, 2013

Last Update Submit

July 17, 2013

Conditions

Apical Periodontitis

Keywords

Apical periodontitisDentaport ZXelectronic apex locatorsi-RootRaypex 5working length

Outcome Measures

Primary Outcomes (1)

  • Actual working length (AWL)

    6 months

Secondary Outcomes (1)

  • Electronic working length (EWL)

    6 months

Other Outcomes (1)

  • working length

    6 months

Study Arms (2)

apical periodontitis (AP)

EXPERIMENTAL

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

Device: Electronic Root Canal Length Measurement Device

normal periapex (NP)

EXPERIMENTAL

clinical pulp vitality periapical index score of 1

Device: Electronic Root Canal Length Measurement Device

Interventions

Electronic Root Canal Length Measurement DeviceDEVICE

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

Also known as: Dentaport ZX, Raypex, i-Root
apical periodontitis (AP)normal periapex (NP)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • single-rooted teeth
  • clinical pulp necrosis and periapical index scores of 3, 4 or 5
  • pulp vitality and a periapical index score of 1

You may not qualify if:

  • Teeth with metal restorations
  • Teeth with prosthetic crowns
  • Teeth with pulp calcification
  • Teeth with previous endodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, 81746-73461, Iran

Location

Related Links

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Masoud Saatchi, DDS MS

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Isfahan University of Medical Sciences

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 22, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations

IR(1)