Root CanalNCT00901810
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length
A study testing Electronic Apex Locator and Dental Radiography in people with Root Canal, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Accurate length determination of root canal is essential in root canal therapy. Radiography has been the conventional method for this measurement but recently several in-vitro studies have shown that new generations of Electronic Apex locators are as accurate as radiography in length determination. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal
- What is being tested?
- Electronic Apex Locator and Dental Radiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIran
- Study dates
- Apr 2009to Aug 2009
- Phase
- Interventional
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All the patients who are referred for Root Canal Therapy
Who cannot join
- Blocked Canals
- Open Apexes
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shiraz University of Medical Sciences - Dental School
Shiraz, Fars
Javad Anvar, DMD, +98-711-6263193 ext. 222, Javad_anvar@yahoo.com
Shohre Ravanshad, DMD, MSD
About this study
Accurate length determination of root canal is essential in root canal therapy. Radiography has been the conventional method for this measurement but recently several in-vitro studies have shown that new generations of Electronic Apex locators are as accurate as radiography in length determination. It is hypothesized that the latest generation of Electronic Apex locator can produce acceptable results as radiography when used for length determination.
- Conditions
- Root Canal
- Being tested
- Electronic Apex Locator, Dental Radiography
- Keywords
- Length Determination, Working Length, Electronic Apex Locator, Root Canal Therapy, Endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Apex LocatorDevice
Also called RootZX, Raypex
Electronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file.
Dental RadiographyDevice
Also called pre apical Radiography
Radiography is used to measure the length of root canal by putting an endodontic file in the canal and taking the radiography to measure the length.
| Study group | Role | What they receive |
|---|---|---|
| Apex Locator | Active comparator | Working length for cleaning and shaping of the canal is measured by Electronic Apex Locator in this group. Receives: Device: Electronic Apex Locator |
| Radiography | Active comparator | Working length for cleaning and shaping of the canal is measured by Radiography in this group. Receives: Device: Dental Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequacy of final working length
Measured: at the end of cleaning and shaping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CanalStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901810
- Sponsor's protocol ID
- sums316
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length
- ClinicalTrials.gov ID
- NCT00901810
- Acronym / sponsor ID
- sums316
- Conditions
- Root Canal
- Keywords
- Length Determination, Working Length, Electronic Apex Locator, Root Canal Therapy, Endodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 14 May 2009 (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.
Accurate length determination of root canal is essential in root canal therapy. Radiography has been the conventional method for this measurement but recently several in-vitro studies have shown that new generations of Electronic Apex locators are as accurate as radiography in length determination. It is hypothesized that the latest generation of Electronic Apex locator can produce acceptable results as radiography when used for length determination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apex Locator | Active comparator | Device: Electronic Apex LocatorWorking length for cleaning and shaping of the canal is measured by Electronic Apex Locator in this group. |
| Radiography | Active comparator | Device: Dental RadiographyWorking length for cleaning and shaping of the canal is measured by Radiography in this group. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients who are referred for Root Canal Therapy
Key exclusion criteria (2 listed)
- Blocked Canals
- Open Apexes
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 |
|---|---|---|
| Electronic Apex LocatorAlso: RootZX, RaypexElectronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file. | Device | Apex Locator |
| Dental RadiographyAlso: pre apical RadiographyRadiography is used to measure the length of root canal by putting an endodontic file in the canal and taking the radiography to measure the length. | Device | Radiography |
Primary outcome
adequacy of final working length
Time frame: at the end of cleaning and shaping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Apex Locator and Dental Radiography in people with Root Canal, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 May 2009. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shohre Ravanshad, MSD (+98-711-6263193 ext. 222, sravanshad@sums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequacy of final working length (time frame: at the end of cleaning and shaping). 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 14 May 2009.