Accuracy of Electronic Apex Locators ProMark, RootZX II and NRG Rider on Working Length of Multi-rooted Teeth

Completed

• Conditions: Dental Pulp Diseases
• Interventions: 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)

• Registration Number: NCT02521909
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-13
• Study Start: 2015-09
• Status Verified: 2017-06
• Primary Completion: 2017-06-21
• Study Completion: 2017-06-21
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tooth Extraction	ProMark (Tooth Extraction for Assessment of Different Apex Locators)	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
Tooth Extraction	NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)	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
Tooth Extraction	Root ZX II (Tooth Extraction for Assessment of Different Apex Locators)	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

Primary Outcome Measures

Name	Time	Method
Tooth Length Measurement after extraction	48 hours 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

Trial Locations

Locations (1)

U of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States