The Prevalence of Bifid Mandibular CanalNCT03804437
The Prevalence and Anatomical Variations of Bifid Mandibular Canal in the Egyptian Population Using Cone Beam CT (CBCT)
An observational study of The Prevalence of Bifid Mandibular Canal, run by Cairo University at 1 site in Egypt.
Trial summary
The prevalence of bifid mandibular canal will be detected in a sample of Egyptian Population.Anatomical variations of the bifid canal will also be detected. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- The Prevalence of Bifid Mandibular Canal
- How many people
- 329 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2019to 15 Oct 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Egyptian population
Who may be able to join
- Age range from 18 to 70
- Scans showing the premolar, molar, retromolar areas.
Who cannot join
- Patients with mandibular lesions.
- Scans with severe metallic artifacts.
- Patients with previous fractures or surgeries.
- Severe bone resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence and Anatomical Variations of Bifid Mandibular Canal in a Sample of Egyptian Population Using CBCT.A Hospital-based Cross-Sectional Study
The prevalence of bifid mandibular canal will be detected in a sample of Egyptian Population.Anatomical variations of the bifid canal will also be detected.
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 bifid canals - Classification and prevalence of observed types - Distance from the involved teeth
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).
- Both images with 0.2 and 0.4 voxel sizes will be reviewed.
- For proper visualization of the mandibular canal, the reference lines will be rotated, so that it lies perpendicular to the mandibular foramen on the axial cuts. Then, scrolling through the corrected sagittal cuts will be performed to review the clearest cut of the full course of the mandibular canal. Moreover, corrected coronal cuts will be reviewed, to determine the exits of the accessory branches (buccal or lingual) if present.
- 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.
- The classification of Naitoh et al 2009 will be followed for the categorization of the accessory branches:
- Forward canal: emerging from the superior wall of the main canal.
- Bucco-lingual canal: emerging from the buccal or the lingual wall of the main canal.
- Dental canal: the end of the bifid canal is at the root apex of the molars.
- Retromolar canal: emerging from the main canal, opening at the retromolar foramen in the retromolar area.
- Each radiologist will evaluate the images for presence of bifid canal twice 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 adherence or closeness of the canals to the teeth is detected, then the distance between the canal and the involved tooth will be measured using built in measuring tool in the software.
- The measurements will be carried out by one observer (EE) and will be repeated 2 weeks later for intra-observer reliability assessment.
Bias
No source of bias.
Study Size:
The aim of the study is to assess the prevalence of bifid mandibular canal in Egyptian population. Based on the previous paper by Afsa and Rahmati 2017, the prevalence of bifid mandibular canal was 31% Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 329 hemimandibles will be sufficient. The sample size was calculated by Epi info 7 software.
Quantitative Variables:
Quantitative data: The distance between the canal and involved teeth and will be reported as mean and standard deviation.
Statistical methods:
Data will be analyzed using SPSS® v. 15 (SPSS Inc., Chicago, IL) software program. Pearson Chi square and t-tests was performed for statistical analysis among gender, localization and measurements. Categorical data will be described as numbers and percentages. A p value of <0.05 will be considered statistically significant.
- Conditions
- The Prevalence of Bifid Mandibular Canal
- Keywords
- Mandibular canals, bifid canal, cbct, cbct dental.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifid mandibular canal detection, measuring device is CBCT software Romexis, measuring unit is percentage ( Dichotomous data - Yes or No )
Detection of bifid mandibular canal in Egyptian population
Measured: up to 2019
Secondary outcomes (1)
Prevalence of types,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data(%)
They are either Forward canal, Bucco-lingual canal , Retromolar canal, Dental canal
Measured: up to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start10 Sep 2019
- Primary completion1 Aug 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Prevalence of Bifid Mandibular CanalStudies 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
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas El Saket, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804437
- Sponsor's protocol ID
- ORAD 7-1-1
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2019
- Last updated
- 27 Jan 2021
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Anatomical Variations of Bifid Mandibular Canal in a Sample of Egyptian Population Using CBCT.A Hospital-based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03804437
- Acronym / sponsor ID
- ORAD 7-1-1
- Conditions
- The Prevalence of Bifid Mandibular Canal
- Keywords
- Mandibular canals, bifid canal, cbct, cbct dental.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 15 Jan 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 prevalence of bifid mandibular canal will be detected in a sample of Egyptian Population.Anatomical variations of the bifid canal will also be detected.
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 bifid canals - Classification and prevalence of observed types - Distance from the involved teeth
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).
- Both images with 0.2 and 0.4 voxel sizes will be reviewed.
- For proper visualization of the mandibular canal, the reference lines will be rotated, so that it lies perpendicular to the mandibular foramen on the axial cuts. Then, scrolling through the corrected sagittal cuts will be performed to review the clearest cut of the full course of the mandibular canal. Moreover, corrected coronal cuts will be reviewed, to determine the exits of the accessory branches (buccal or lingual) if present.
- 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.
- The classification of Naitoh et al 2009 will be followed for the categorization of the accessory branches:
- Forward canal: emerging from the superior wall of the main canal.
- Bucco-lingual canal: emerging from the buccal or the lingual wall of the main canal.
- Dental canal: the end of the bifid canal is at the root apex of the molars.
- Retromolar canal: emerging from the main canal, opening at the retromolar foramen in the retromolar area.
- Each radiologist will evaluate the images for presence of bifid canal twice 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 adherence or closeness of the canals to the teeth is detected, then the distance between the canal and the involved tooth will be measured using built in measuring tool in the software.
- The measurements will be carried out by one observer (EE) and will be repeated 2 weeks later for intra-observer reliability assessment.
Bias
No source of bias.
Study Size:
The aim of the study is to assess the prevalence of bifid mandibular canal in Egyptian population. Based on the previous paper by Afsa and Rahmati 2017, the prevalence of bifid mandibular canal was 31% Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 329 hemimandibles will be sufficient. The sample size was calculated by Epi info 7 software.
Quantitative Variables:
Quantitative data: The distance between the canal and involved teeth and will be reported as mean and standard deviation.
Statistical methods:
Data will be analyzed using SPSS® v. 15 (SPSS Inc., Chicago, IL) software program. Pearson Chi square and t-tests was performed for statistical analysis among gender, localization and measurements. Categorical data will be described as numbers and percentages. A p value of <0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian population
Key inclusion criteria (2 listed)
- Age range from 18 to 70
- Scans showing the premolar, molar, retromolar areas.
Key exclusion criteria (4 listed)
- Patients with mandibular lesions.
- Scans with severe metallic artifacts.
- Patients with previous fractures or surgeries.
- Severe bone resorption.
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
Bifid mandibular canal detection, measuring device is CBCT software Romexis, measuring unit is percentage ( Dichotomous data - Yes or No )
Time frame: up to 2019
Detection of bifid mandibular canal in Egyptian population
1 secondary outcome
Prevalence of types,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data(%)
Time frame: up to 2019
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 27 Jan 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Prevalence of Bifid Mandibular Canal, run by Cairo University at 1 site in Egypt.
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 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 27 Jan 2021. 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 Egypt. 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?
Bifid mandibular canal detection, measuring device is CBCT software Romexis, measuring unit is percentage ( Dichotomous data - Yes or No ) (time frame: up to 2019). 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 27 Jan 2021.