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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine
Cairo
Central evidence Based Commitee-CU CEBD, (+20)23642938, cebd@dentistry.cu.edu.eg
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
- 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.
- 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.
- Conditions
- C-shaped Root Canal
- 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.
Prevalence of C-shaped root canal in the whole sample
Using CBCT / Binary system (Yes/No)
Measured: Immediately
Secondary outcomes (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.
- First posted17 Aug 2018
- Study start1 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for C-shaped Root CanalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Abdel Aziz, Cairo University
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 15564875Fan 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03635203
- Acronym / sponsor ID
- C-shaped_root_canal
- Conditions
- C-shaped Root Canal
- Keywords
- C-shaped root canal / C-shaped canals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCTAlso: Cone beam computed tomographyObservation of C-shaped root canal in mandibular first and second molars in Egyptian sub-population | Device | – |
Primary outcome
Prevalence of C-shaped root canal in the whole sample
Time frame: Immediately
Using CBCT / Binary system (Yes/No)
1 secondary outcome
Configurations of C-shaped canals of mandibular first and second molars in the whole sample
Time frame: Immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Background: PubMed 15564875Fan 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.
- Background: PubMed 15564874Fan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.