Dental Pulp DiseasesNCT02521909
Accuracy of Electronic Apex Locators ProMark, RootZX II and NRG Rider on Working Length of Multi-rooted Teeth
An observational study of Dental Pulp Diseases, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Diseases
- What is being tested?
- ProMark (Tooth Extraction for Assessment of Different Apex Locators), Root ZX II (Tooth Extraction for Assessment of Different Apex Locators) and NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 21 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals in need of extraction of multi-rooted teeth
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
U of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Pulp Diseases
- Being tested
- ProMark (Tooth Extraction for Assessment of Different Apex Locators), Root ZX II (Tooth Extraction for Assessment of Different Apex Locators), NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)
- Keywords
- Root Canal length, Electronic apex locator, Endodontics
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProMark (Tooth Extraction for Assessment of Different Apex Locators)Device
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.
Root ZX II (Tooth Extraction for Assessment of Different Apex Locators)Device
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.
NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours After Extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neville McDonald, University of Michigan
- Investigators
- Neville McDonald, BDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521909
- Sponsor's protocol ID
- HUM00093162
- Status last verified
- Jun 2017
- First submitted
- 7 Aug 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An in Vivo Evaluation of the ProMark, Root ZX II, and NRG Rider Electronic Apex Locators on the Accuracy of Working Length of Molars
- ClinicalTrials.gov ID
- NCT02521909
- Acronym / sponsor ID
- HUM00093162
- Conditions
- Dental Pulp Diseases
- Keywords
- Root Canal length, Electronic apex locator, Endodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth Extraction | – | 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)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals in need of extraction of multi-rooted teeth
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Tooth Extraction |
| 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 | Tooth Extraction |
| 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. | Device | Tooth Extraction |
Primary outcome
Tooth Length Measurement after extraction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neville McDonald, BDS, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth Length Measurement after extraction (time frame: 48 hours After Extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.