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Status unknownNCT03935711Updated Aug 1, 2019

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 in Number of Root Canals and it's Configurations in Lower Anteriors, sponsored by Cairo University. Status unknown. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
167
Ages
10 Years to 60 Years
Sex
All
01

Study 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

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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.

02

Conditions studied

  • Number of Root Canals and it's Configurations in Lower Anteriors

Keywords

  • cbct
  • cbct dental
  • mandibular anterior teeth
  • canal morphology
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Egyptian population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scans showing the anterior teeth areas.
  • The teeth had to be completely developed

Exclusion criteria

Exclusion criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
167 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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 %

    Time frame: 2019

  2. 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 %

    Time frame: 2019

  3. the root canal configuration in mandibular anterior teeth

    the consequestial configuration of root canals through Oblique Reformatted cuts,measuring unit is categorical nominal data %

    Time frame: 2019

Secondary outcomes

  1. 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.

    Time frame: 2019

  2. 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

    Time frame: 2019

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03935711
Lead sponsor
Cairo University
Responsible party
Passant Yusuf Abulabas (masters degree student, Cairo University) — Principal investigator
First posted
May 2, 2019
Start date
Sep 15, 2019 (estimated)
Primary completion
Jul 30, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Aug 1, 2019

Study contacts

Passant Yusuf, masters degree student
Contact
pass.yusuf@gmail.com
01555520970

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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