Endodontic DiseaseNCT03680534
3D Analysis of Root Canal Conformation
A study testing Root canal preparation in people with Endodontic Disease and Root Canal Infection, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
Trial summary
Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Root Canal Infection
- What is being tested?
- Root canal preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 24 Aug 2017to 19 Nov 2017
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
- healthy conditions
- not medicated with any type of drug
- non-smoking patients
- lower premolars indicated for extraction due to orthodontic reasons
- lower premolar with more than one root canal
Who cannot join
- Not willing to participate
- Pregnant women
- lower premolars with previous root canal therapy
- lower premolars with
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Analysis of the Root Canal Preparation With Reciproc Blue, WaveOne Gold and XP EndoShaper
Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in vivo.
Methodology Thirty human lower premolars were randomly divided into three groups, in which root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering ability of the instrument and canal transportation for each group. Statistical analysis was made for each variable to determine statistically significant differences between groups.
- Conditions
- Endodontic Disease, Root Canal Infection
- Being tested
- Root canal preparation
- Keywords
- root canal preparation, single-file preparation techniques, 3D reconstruction
- 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.
Root canal preparationProcedure or surgery
Also called Root canal instrumentation
Root canals from lower premolars with extraction indicated were prepared previous to being extracted with either the Reciproc Blue, the WaveOne Gold or the XP EndoShaper single-file techniques.
| Study group | Role | What they receive |
|---|---|---|
| Reciproc Blue | Experimental | Patients in which root canal from a lower premolar was prepared with the Reciproc Blue technique. Receives: Procedure: Root canal preparation |
| WaveOne Gold | Experimental | Patients in which root canal from a lower premolar was prepared with the WaveOne Gold technique. Receives: Procedure: Root canal preparation |
| XP EndoShaper | Experimental | Patients in which root canal from a lower premolar was prepared with the XP EndoShaper technique. Receives: Procedure: Root canal preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software
The total volume of the root canal measured before and after root canal preparation by using the volume command in the Rhinoceros 5.0 software which gives the volume of a solid in cubic millimetres.
Measured: One day
Root canal transportation after preparation assessed by superimposing three-dimensional reconstruction images of pre- and post-preparation
Deviation of the original anatomy of the canal to the mesial or distal wall after root canal preparation evaluated by superimposing three-dimensional reconstruction images of the canal before and after preparation.
Measured: One day
Centring ability of the instruments used to prepare the root canal assessed by determining if canal was enlarged equally to each of its walls
Ability of the instruments used for root canal preparation to equally enlarge all of the canal walls, evaluated by analysing superimposed three-dimensional reconstructed images of before and after root canal preparation.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start24 Aug 2017
- Primary completion23 Oct 2017
- Study completion19 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institucion Universitaria Colegios de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Caviedes-Bucheli, Institucion Universitaria Colegios de Colombia
- Investigators
- Javier Caviedes-Bucheli, Principal investigator, Institucion Universitaria Colegios de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680534
- Sponsor's protocol ID
- JCB001
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Analysis of the Root Canal Preparation With Reciproc Blue, WaveOne Gold and XP EndoShaper
- ClinicalTrials.gov ID
- NCT03680534
- Acronym / sponsor ID
- JCB001
- Conditions
- Endodontic Disease, Root Canal Infection
- Keywords
- root canal preparation, single-file preparation techniques, 3D reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institucion Universitaria Colegios de ColombiaUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 19 Nov 2017 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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.
Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in vivo.
Methodology Thirty human lower premolars were randomly divided into three groups, in which root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering ability of the instrument and canal transportation for each group. Statistical analysis was made for each variable to determine statistically significant differences between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reciproc Blue | Experimental | Procedure: Root canal preparationPatients in which root canal from a lower premolar was prepared with the Reciproc Blue technique. |
| WaveOne Gold | Experimental | Procedure: Root canal preparationPatients in which root canal from a lower premolar was prepared with the WaveOne Gold technique. |
| XP EndoShaper | Experimental | Procedure: Root canal preparationPatients in which root canal from a lower premolar was prepared with the XP EndoShaper technique. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-30 years old
- healthy conditions
- not medicated with any type of drug
- non-smoking patients
- lower premolars indicated for extraction due to orthodontic reasons
Key exclusion criteria (4 listed)
- Not willing to participate
- Pregnant women
- lower premolars with previous root canal therapy
- lower premolars with
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 |
|---|---|---|
| Root canal preparationAlso: Root canal instrumentationRoot canals from lower premolars with extraction indicated were prepared previous to being extracted with either the Reciproc Blue, the WaveOne Gold or the XP EndoShaper single-file techniques. | Procedure or surgery | Reciproc Blue, WaveOne Gold, XP EndoShaper |
Primary outcome
Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software
Time frame: One day
The total volume of the root canal measured before and after root canal preparation by using the volume command in the Rhinoceros 5.0 software which gives the volume of a solid in cubic millimetres.
Root canal transportation after preparation assessed by superimposing three-dimensional reconstruction images of pre- and post-preparation
Time frame: One day
Deviation of the original anatomy of the canal to the mesial or distal wall after root canal preparation evaluated by superimposing three-dimensional reconstruction images of the canal before and after preparation.
Centring ability of the instruments used to prepare the root canal assessed by determining if canal was enlarged equally to each of its walls
Time frame: One day
Ability of the instruments used for root canal preparation to equally enlarge all of the canal walls, evaluated by analysing superimposed three-dimensional reconstructed images of before and after root canal preparation.
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 21 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Javier Caviedes-Bucheli principal investigator
Institucion Universitaria Colegios de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal preparation in people with Endodontic Disease and Root Canal Infection, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
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 6 inclusion and 4 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 21 Sep 2018. 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 Colombia. 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?
Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software (time frame: One day). The study lists 3 primary outcomes in all. 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 21 Sep 2018.