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

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.

Study Overview

• Status: Completed
• Conditions: Dental Pulp Diseases
• Intervention / Treatment: Device: ProMark (Tooth Extraction for Assessment of Different Apex Locators); Device: Root ZX II (Tooth Extraction for Assessment of Different Apex Locators); Device: NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)

Detailed Description

This study will generate data to compare the efficacy of three different manufactures of an instrument commonly used in dental clinics. The instruments are known as electronic apex locators (EAL). Electronic apex locators are used to measure the length of a root canal and to locate its opening at the end 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 diseased, dentists may perform root canal therapy; for this reason the accuracy of the EAL is very important.

In this study patients who are scheduled for tooth extraction as part of their standard of care will be pre-screened by record review for candidacy as study subjects. If the scheduled patients screen as potentially eligible by reviewing their records, then they will be approached by the study team at the time of their pre-extraction consultation visit (this is a visit which occurs prior to the extraction visit). Only teeth scheduled to be extracted are suitable for this study. On the day of their standard of care tooth or teeth extraction(s) prior to the extraction the study team will conduct measurements with the EALs. After the EAL measurements the standard of care extractions will occur as standard of care, outside of the study, and by the patient's clinician. Extracted teeth will be given to the study team as long as they are not needed for further pathological review (extracted teeth are usually discarded and are rarely sent to a lab for further analysis). Also the teeth must be extracted without breaking. the study team will analyze them (ex-vivo) to generate true root measurements which will be compared to the data generated prior to extraction by the instruments which are the subject of this study. The instruments are the subject of this study, but in-vivo data generated by the instruments will be compared to ex-vivo data gained by measurements after the tooth/teeth is/are extracted.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • U of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals in need of extraction of multi-rooted teeth

Description

Inclusion criteria:

1. Be an adult over 18 years of age.
2. Multi-rooted teeth (molar or premolar) scheduled for extraction because of non-restorability, orthodontic or periodontal reasons
3. Be able to understand and provide informed consent for participation in the protocol

Exclusion criteria:

1. Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol or interpretation of the results difficult
2. History of syphilis, HIV, Hepatitis B or Hepatitis C
3. Pregnant
4. Currently receiving radiation
5. Any other medical/physical condition the PI deems unacceptable for participation.
6. Patient unable to provide informed consent
7. Plan to participate in another clinical trial within 30 days of entrance into this study
8. Tooth with "non-intact crown"
9. Presence of an electronic implantable device (pacemaker, etc)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: ProMark (Tooth Extraction for Assessment of Different Apex Locators); 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.; Device: Root ZX II (Tooth Extraction for Assessment of Different Apex Locators); 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.; Device: NRG Rider (Tooth Extraction for Assessment of Different Apex Locators); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Neville McDonald, BDS, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Endodontics; Root Canal length; Electronic apex locator
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases
• Other Study ID Numbers: HUM00093162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No