Accuracy of Electronic Apex Locators ProMark, RootZX II and NRG Rider on Working Length of Multi-rooted Teeth
An in Vivo Evaluation of the ProMark, Root ZX II, and NRG Rider Electronic Apex Locators on the Accuracy of Working Length of Molars
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this study is to compare the accuracy of different apex locators. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
1 active site
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
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2017
CompletedJune 22, 2017
June 1, 2017
1.8 years
August 7, 2015
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tooth Length Measurement after extraction
A Kodak 9000 3D is used as a small-volume field of view (FOV) CBCT based on its scan to allow cone beam reconstructions at 0.076 mm with a minimal discrepancy compared to histologic sections. The extracted teeth are imaged and slices reviewed for accuracy
48 hours After Extraction
Study Arms (1)
Tooth Extraction
Intervention is Tooth Extraction for Assessment of Different Apex Locators. All people in the study will contribute one or more teeth, which will be extracted for other clinical purposes, for device comparative testing
Interventions
The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
Eligibility Criteria
Individuals in need of extraction of multi-rooted teeth
You may qualify if:
- Be an adult over 18 years of age.
- Multi-rooted teeth (molar or premolar) scheduled for extraction because of non-restorability, orthodontic or periodontal reasons
- Be able to understand and provide informed consent for participation in the protocol
You may not qualify if:
- Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol or interpretation of the results difficult
- History of syphilis, HIV, Hepatitis B or Hepatitis C
- Pregnant
- Currently receiving radiation
- Any other medical/physical condition the PI deems unacceptable for participation.
- Patient unable to provide informed consent
- Plan to participate in another clinical trial within 30 days of entrance into this study
- Tooth with "non-intact crown"
- Presence of an electronic implantable device (pacemaker, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neville McDonald, BDS, MS
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor, Director of Endodontics
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 13, 2015
Study Start
September 1, 2015
Primary Completion
June 21, 2017
Study Completion
June 21, 2017
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share