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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculty of dentistry, Cairo University

    Cairo

Other trials in Egypt

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:
  1. Forward canal: emerging from the superior wall of the main canal.
  2. Bucco-lingual canal: emerging from the buccal or the lingual wall of the main canal.
  3. Dental canal: the end of the bifid canal is at the root apex of the molars.
  4. 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.

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.

  1. 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)
  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.

  1. First posted15 Jan 2019
  2. Study start10 Sep 2019
  3. Primary completion1 Aug 2020
  4. Study completion15 Oct 2020

Resources

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)
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

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.

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