AzTrials
AzTrials

C-shaped Root CanalNCT03635203

C-shaped Root Canal Prevalence and Configurations in Egyptians

An observational study of C-shaped Root Canal, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 15 to 70 yearsHealthy volunteers can take part
Conditions the study is for
C-shaped Root Canal
What is being tested?
CBCT
Type of treatment
Medical device
How many people
374 participants
Where
1 siteEgypt
Study dates
1 Sep 2020to 1 Jan 2021
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 15 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • root canal calcification or a periapical lesion (s)
  • previous root canal treatment
  • post or crown restoration
  • evidence of apicectomy or periapical surgery.
  • developmental anomalies.

Trial locations and contacts

1 site in 1 country.

Doaa M Abdel Aziz, Student contact

(+20)1008483209

doaa.abdelaziz@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Oral and Dental Medicine

    Cairo

    Central evidence Based Commitee-CU CEBD, (+20)23642938, cebd@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: C-shaped Root Canal System Prevalence and Configurations of Mandibular First and Second Molars in an Egyptian Sub-population Evaluated by Cone-beam Computed Tomography: A Cross-Sectional Observational Study

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.

Read the detailed description
  1. Scientific Background: The main goal of conventional root canal treatment is to prevent or heal apical periodontitis through cleaning, shaping and three-dimensional obturation of the root canal system. To establish this goal; recognition of root canal anatomy is required to minimize the risk of treatment failure. Studies recorded variations among different ethnicities in the prevalence and configurations of some root canal systems in particular interest is the root canal configurations of the mandibular first and second molars. Anatomical variations recorded include radix entomolaris, radix paramolaris and C-shaped canal. The prevalence of C-shaped root canal ranges between 2.6% to 44.5% among different ethnicities with the highest percentage in Asian populations. C-shaped root canal anatomy has challenges in the diagnosis and endodontic management. Challenge in diagnosis is attributed to the variations in the root canal anatomy that may extend along the entire length of the canal. Preoperative identification of C-shaped root canal and its configurations is difficult by conventional radiographic techniques due to their inherent limitations. Challenges in endodontic management are attributed to the presence of complex isthmi, fins and webs connecting the individual root canals that may complicate the proper cleaning and shaping of the root canal rendering it more difficult. Therefore, it is important to detect and identify the configuration of C-shaped canals before root canal treatment. Preoperative recognition of the prevalence and root canal configurations will direct the attention of endodontists to its presence and will facilitate the root canal accessing, negotiation, determining the best three-dimensional instrumentation and obturation technique.
  2. Rationale of the study:

Different methods have been used to investigate the prevalence and configurations of C-shaped root canal including: microscopic examination of extracted demineralized teeth after black ink infiltration or microscopic examination for polyester cast resin of the pulp space of demineralized extracted teeth or microscopic examination of extracted teeth with methylene blue dye infiltration followed by resin imbibition, conventional radiography, medical CT and most recently CBCT.

CBCT was reported to be accurate for various root canals morphological analysis because of the 3-dimensional reconstruction of the internal and external morphology of the tooth and high spatial resolution in all planes. It has the ability to investigate the morphology of the root canal system without intervention. Compared to medical CT, CBCT can be accomplished with a substantially lower effective dose and reduced acquisition time.

According to my knowledge, there is only one study that has investigated the prevalence of the C-shaped root canal in mandibular first and second molars among members of sub-Egyptian population, but the configurations of C-shaped root canal have not been studied yet.

Knowledge of the prevalence rate and root canal configurations will direct the attention of endodontists to its presence and will facilitate the root canal accessing, negotiation, determining the best instrumentation and obturation technique thus, long term success rate of the endodontic therapy.

Being tested
CBCT
Keywords
C-shaped root canal / C-shaped canals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBCTDevice

    Also called Cone beam computed tomography

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of C-shaped root canal in the whole sample

    Using CBCT / Binary system (Yes/No)

    Measured: Immediately

Secondary outcomes (1)
  1. Configurations of C-shaped canals of mandibular first and second molars in the whole sample

    Using CBCT / Percentage

    Measured: Immediately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Jan 2021 (estimated)

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
Retrospective
Enrolment
374 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635203
Sponsor's protocol ID
C-shaped_root_canal
Status last verified
Sep 2019
First submitted
15 Aug 2018
Last updated
9 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15564875
  • 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.

    PubMed 15564874

Questions about this trial

What is this clinical trial studying?

An observational study of C-shaped Root 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 11 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Doaa M Abdel Aziz, Student ((+20)1008483209, doaa.abdelaziz@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of C-shaped root canal in the whole sample (time frame: Immediately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635203, which also lists 2 linked publications.

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 9 Sep 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in