NCT03635203

Brief Summary

The aim of this study is to investigate the prevalence and configuration of C-shaped root canal of mandibular first and second molars among members of an Egyptian sub-population using cone beam computed tomography (CBCT). The prevalence and distribution of the C-shape canal configurations with respect to gender and age will be also investigated. Data regarding the prevalence and configurations of C-shaped root canal in the first and the second mandibular molars in Egyptian sub-population is lacking which might affect the correct implementation of chemo-mechanical instrumentation and obturation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

August 15, 2018

Last Update Submit

September 5, 2019

Conditions

Keywords

C-shaped root canal / C-shaped canals

Outcome Measures

Primary Outcomes (1)

  • Prevalence of C-shaped root canal in the whole sample

    Using CBCT / Binary system (Yes/No)

    Immediately

Secondary Outcomes (1)

  • Configurations of C-shaped canals of mandibular first and second molars in the whole sample

    Immediately

Interventions

CBCTDEVICE

Observation of C-shaped root canal in mandibular first and second molars in Egyptian sub-population

Also known as: Cone beam computed tomography

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. The data collection will be obtained from the data base available at a private radiographic center (oral and maxillofacial imaging center located in Cairo, Egypt). 2. CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination including diagnosis, treatment planning and follow-up during the years before 2015.

You may qualify if:

  • CBCT images of good quality at which the mandibular first and second molars could be seen adequately.
  • Mandibular first and second molars with fully developed roots.

You may not qualify if:

  • Tomographic images of poor quality or artifacts interfering with the detection of the root canals
  • Tomographic images without demographic data including gender and age of the patient
  • Mandibular first and second molars having:
  • coronal fillings or deep caries reaching the pulp floor
  • root caries specially reaching the bifurcation area or root fracture
  • external or internal root resorption
  • root canal calcification or a periapical lesion (s)
  • previous root canal treatment
  • post or crown restoration
  • evidence of apicectomy or periapical surgery.
  • developmental anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Fan B, Cheung GS, Fan M, Gutmann JL, Fan W. C-shaped canal system in mandibular second molars: Part II--Radiographic features. J Endod. 2004 Dec;30(12):904-8. doi: 10.1097/01.don.0000136206.73115.93.

    PMID: 15564875BACKGROUND
  • Fan B, Cheung GS, Fan M, Gutmann JL, Bian Z. C-shaped canal system in mandibular second molars: Part I--Anatomical features. J Endod. 2004 Dec;30(12):899-903. doi: 10.1097/01.don.0000136207.12204.e4.

    PMID: 15564874BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A total of 374 CBCT scans of mandibular first and second permanent molars belonging to Egyptian individuals.

MeSH Terms

Interventions

Cone-Beam Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Central Study Contacts

Doaa M Abdel Aziz, Student

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student at Endodontic department. Faculty of Oral and Dental Medicine

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 17, 2018

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations