Number of Root Canals and it's Configurations in Lower AnteriorsNCT03935711
The Prevalence of Extra Root Canals and the Root Canal Configuration in Mandibular Anterior Teeth in a Sample of Egyptian Population Using Cone Beam Computed Tomography
An observational study of Number of Root Canals and it's Configurations in Lower Anteriors, run by Cairo University.
Trial summary
The considerable incidence of extra root canals of anterior mandibular teeth that is usually missed due to lack of knowledge and scarce studies leading to improper endodontic treatment, Therefore, endodontists are in need of additional investigations to enhance the quality of the root canal treatment to avoid failure Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Number of Root Canals and it's Configurations in Lower Anteriors
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 30 Sep 2020
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Egyptian population
Who may be able to join
- Scans showing the anterior teeth areas.
- The teeth had to be completely developed
Who cannot join
- Teeth to be examined, endodontically treated teeth.
- Teeth with crown restorations.
- Cast metal post inside the canal
- Teeth with apical lesions.
- Carious teeth
- Scans with low quality
- Dilacerated roots
- Resorbed roots
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Prevalence of Extra Root Canals and the Root Canal Configuration in Mandibular Anterior Teeth in a Sample of Egyptian Population Using Cone Beam Computed Tomography. A Hospital-based Cross-Sectional Study
The considerable incidence of extra root canals of anterior mandibular teeth that is usually missed due to lack of knowledge and scarce studies leading to improper endodontic treatment, Therefore, endodontists are in need of additional investigations to enhance the quality of the root canal treatment to avoid failure
Read the detailed description
Settings:
The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes.
Variables:
•Prevalence of extra root canals in mandibular anterior teeth - Classification and prevalence of observed types -
Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations). images with 0.2 voxel size will be reviewed.
- For proper visualization of the canals number and configuration in anterior mandibular teeth, scrolling through the three orthogonal cuts and oblique reformatted planes.
- CBCT images will be interpreted by two oral and maxillofacial radiologists (with different experiences) independently; blinded from demographic data of the patients and from the results of each other.
- Vertucci classified the canal configurations of mandibular anterior teeth into four types (Vertucci, 1974) :
Type I: Single canal is present from the pulp chamber to the apex. Type II: Two separate canal leaves the pulp chamber, but join short of the apex to form one canal.
Type III: One canal leaves the pulp chamber, but it divides into two within the body of the root, the canals merge again to exist as one canal.
Type IV: Two separate and distinct canals are present from the pulp chamber to apex.
Type V: A single canal leaves the pulp chamber but divides into 2. Type VI: 2 separate canals leave the pulp chamber, join at the midpoint, and then divide again into 2 with 2 separate apical foramina.
Type VII: 1 canal leaves the pulp chamber, divides and then rejoins within the root, and finally redivides into 2 separate canals with 2 separate apical foramina.
Type VIII: 3 separate and distinct canals begin from the pulp chamber to the root apex.
- Each radiologist will evaluate the images for presence of extra root canal with a time lag of two weeks between the two reading sessions. If present, its configuration (classification) will be registered. Any disagreement will be solved by consensus between the two observers.
- If extra root canals type II , type IV or type VI is detected, then the distance between the canal orifices will be measured using built in measuring tool in the software.
- The measurements will be carried out by one observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment. Bias No source of bias.
Study Size:
Based on the Iranian paper by Haghanifar et al., 2017, the prevalence of two root canals in mandibular anterior teeth (12.1%) Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval) a total sample size of 170 mandibular anterior tooth will be sufficient. The sample size was calculated by Epi info 7 software.
- Keywords
- cbct, cbct dental, mandibular anterior teeth, canal morphology
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of root canal in mandibular anterior teeth
detection number of canals in mandibular anterior teeth through Oblique Reformatted cuts,measuring unit is categorical nominal data %
Measured: 2019
the number of root in mandibular anterior teeth
detection number of roots in mandibular anterior teeth through Oblique Reformatted cuts,measuring unit is categorical nominal data %
Measured: 2019
the root canal configuration in mandibular anterior teeth
the consequestial configuration of root canals through Oblique Reformatted cuts,measuring unit is categorical nominal data %
Measured: 2019
Secondary outcomes (2)
prevalence of multi-root canal according to gender
detect the prevalence according to gender, measuring unit is categorical nominal data % they are either male or female.
Measured: 2019
the distance between the root canal orifices in lower anteriors
the distance between the root canal orifices in type II, type IV or type VI ,measuring unit Built-in measuring tool (ruler) axial cut
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start15 Sep 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of Root Canals and it's Configurations in Lower AnteriorsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passant Yusuf Abulabas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935711
- Sponsor's protocol ID
- ORAD 7-1
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Extra Root Canals and the Root Canal Configuration in Mandibular Anterior Teeth in a Sample of Egyptian Population Using Cone Beam Computed Tomography. A Hospital-based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03935711
- Acronym / sponsor ID
- ORAD 7-1
- Keywords
- cbct, cbct dental, mandibular anterior teeth, canal morphology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 2 May 2019 (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.
The considerable incidence of extra root canals of anterior mandibular teeth that is usually missed due to lack of knowledge and scarce studies leading to improper endodontic treatment, Therefore, endodontists are in need of additional investigations to enhance the quality of the root canal treatment to avoid failure
Detailed description
Settings:
The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes.
Variables:
•Prevalence of extra root canals in mandibular anterior teeth - Classification and prevalence of observed types -
Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations). images with 0.2 voxel size will be reviewed.
- For proper visualization of the canals number and configuration in anterior mandibular teeth, scrolling through the three orthogonal cuts and oblique reformatted planes.
- CBCT images will be interpreted by two oral and maxillofacial radiologists (with different experiences) independently; blinded from demographic data of the patients and from the results of each other.
- Vertucci classified the canal configurations of mandibular anterior teeth into four types (Vertucci, 1974) :
Type I: Single canal is present from the pulp chamber to the apex. Type II: Two separate canal leaves the pulp chamber, but join short of the apex to form one canal.
Type III: One canal leaves the pulp chamber, but it divides into two within the body of the root, the canals merge again to exist as one canal.
Type IV: Two separate and distinct canals are present from the pulp chamber to apex.
Type V: A single canal leaves the pulp chamber but divides into 2. Type VI: 2 separate canals leave the pulp chamber, join at the midpoint, and then divide again into 2 with 2 separate apical foramina.
Type VII: 1 canal leaves the pulp chamber, divides and then rejoins within the root, and finally redivides into 2 separate canals with 2 separate apical foramina.
Type VIII: 3 separate and distinct canals begin from the pulp chamber to the root apex.
- Each radiologist will evaluate the images for presence of extra root canal with a time lag of two weeks between the two reading sessions. If present, its configuration (classification) will be registered. Any disagreement will be solved by consensus between the two observers.
- If extra root canals type II , type IV or type VI is detected, then the distance between the canal orifices will be measured using built in measuring tool in the software.
- The measurements will be carried out by one observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment. Bias No source of bias.
Study Size:
Based on the Iranian paper by Haghanifar et al., 2017, the prevalence of two root canals in mandibular anterior teeth (12.1%) Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval) a total sample size of 170 mandibular anterior tooth will be sufficient. The sample size was calculated by Epi info 7 software.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Egyptian population
Key inclusion criteria (2 listed)
- Scans showing the anterior teeth areas.
- The teeth had to be completely developed
Key exclusion criteria (8 listed)
- Teeth to be examined, endodontically treated teeth.
- Teeth with crown restorations.
- Cast metal post inside the canal
- Teeth with apical lesions.
- Carious teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the number of root canal in mandibular anterior teeth
Time frame: 2019
detection number of canals in mandibular anterior teeth through Oblique Reformatted cuts,measuring unit is categorical nominal data %
the number of root in mandibular anterior teeth
Time frame: 2019
detection number of roots in mandibular anterior teeth through Oblique Reformatted cuts,measuring unit is categorical nominal data %
the root canal configuration in mandibular anterior teeth
Time frame: 2019
the consequestial configuration of root canals through Oblique Reformatted cuts,measuring unit is categorical nominal data %
2 secondary outcomes
prevalence of multi-root canal according to gender
Time frame: 2019
the distance between the root canal orifices in lower anteriors
Time frame: 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Number of Root Canals and it's Configurations in Lower Anteriors, run by Cairo University.
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 2 inclusion and 8 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Passant Yusuf, masters degree student (01555520970, pass.yusuf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of root canal in mandibular anterior teeth (time frame: 2019). 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 1 Aug 2019.