Accuracy of Electronic Apex Locators ProMark, RootZX II and NRG Rider on Working Length of Multi-rooted Teeth
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/23/2017 |
| Start Date: | September 2015 |
| End Date: | June 21, 2017 |
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.
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.
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.
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.
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)
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