- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935711
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
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
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Passant Yusuf, masters degree student
- Phone Number: 01555520970
- Email: pass.yusuf@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Scans showing the anterior teeth areas.
- The teeth had to be completely developed
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 %
|
2019
|
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 %
|
2019
|
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 %
|
2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of multi-root canal according to gender
Time Frame: 2019
|
detect the prevalence according to gender, measuring unit is categorical nominal data % they are either male or female.
|
2019
|
the distance between the root canal orifices in lower anteriors
Time Frame: 2019
|
the distance between the root canal orifices in type II, type IV or type VI ,measuring unit Built-in measuring tool (ruler) axial cut
|
2019
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ORAD 7-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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