Second Mesiobuccal CanalCBCTNCT03225573
Prevalence of Second Mesiobuccal Canal of Maxillary First and Second Molars Among Egyptian Population
An observational study of Second Mesiobuccal Canal and Maxillary First and Second Molars, run by Cairo University at 1 site in Egypt.
Trial summary
a cross-sectional study to estimate the prevalence of a second mesiobuccal canal of maxillary first and second molars in Egyptian population using cone beam computed tomography through retrospective data analysis Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Second Mesiobuccal Canal, Maxillary First and Second Molars
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 5 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Egyptian Population
Who may be able to join
- First and second maxillary permanent molars of Egyptian patients starting from 15 years, males or females
- Intact roots without fractures or cracks
- Molars without posts or previous root canal treatment
- CBCT scans of maxillary first and second molars using 8 × 6 Field of view, 0.2 voxel resolution
Who cannot join
- Evidence of apicectomy or periapical surgery
- Odontogenic or non-odontogenic pathology
- Maxillary molars with developmental anomalies
- External or Internal Root resorption
- Canal Calcification
- Previous root canal treatment
Show all 10Show fewer
- Extensive coronal restorations
- Posts or crown restorations
- Root caries specially reaching the trifurcation area
- Tomographic images of poor quality or artifacts interfering with the detection of root canals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of a Second Mesiobuccal Canal of Maxillary First and Second Molars Using CBCT Among Egyptian Population: A Cross-Sectional Study
a cross-sectional study to estimate the prevalence of a second mesiobuccal canal of maxillary first and second molars in Egyptian population using cone beam computed tomography through retrospective data analysis
Read the detailed description
Setting and Location:
- The data collection will be obtained from the data base available at a private radiographic centre ORASCAN Oral \& Maxillofacial Imaging Centre located in Cairo, Egypt.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.
Participants:
A total of 196 CBCT scans of Maxillary first and second permanent molars belonging to Egyptian individuals will be included.
Variables:
- Number of root canals in mesiobuccal root of first and second maxillary molars
- Sex of the patient will be identified and addressed as the prevalence of the second mesiobuccal canal may show sex predilection
Data Sources / Measurements:
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
All the CBCT examinations were scanned using Cranex® 3D SOREDEX, 0.2 voxel resolution, 8 × 6 cm FOV, 90 kVp, 10 mA and 6 seconds exposure time.
CBCT images will be analysed in the 3 planes; first the sagittal and coronal sections will be oriented parallel to the long axis of the root, and then sections will be obtained on the axial plane for detection of the 2nd mesiobuccal canal.
CBCT images will be interpreted by three oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
Each one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
Then inter-observational and intra-observational variability between the observers will be evaluated.
The sex of the patient will be identified from the patient's demographic data available on the patient's file on the database of the private radiographic centre.
Bias:
No source of bias.
Study Size:
The aim of the study is to assess the prevalence of a second mesiobuccal canal of maxillary first and second molars in Egyptian population. Based on the previous paper by Nikoloudaki et al, 2015, the prevalence of Second Mesiobuccal Canal of Maxillary First and Second Molars was 89 and 85%. Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 196 will be sufficient. The sample size was calculated by Epi info.
Sampling Strategy: The sample will be collected by simple random sampling.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with second mesiobuccal canal will be counted to estimate the prevalence of the second mesiobuccal canal.
Statistical Methods:
- Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between male and females for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
- If the patient's age couldn't be found in the patient's file, the dental age will be used.
- If the patient's sex couldn't be found in the patient's file, the patient's name will be used to indicate the sex. Patients with mixed name will be excluded.
- Keywords
- second mesiobuccal canal CBCT prevalence population
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Maxillary Molars With a Second Mesiobuccal Canal
measuring device is CBCT software On Demand 3D® , measuring unit is binary system (yes/no)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Feb 2018
- Primary completion15 Apr 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Second Mesiobuccal 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Nashwa Salah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225573
- Sponsor's protocol ID
- Rad2:5:1
- Acronym
- CBCT
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2017
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of a Second Mesiobuccal Canal of Maxillary First and Second Molars Using CBCT Among Egyptian Population: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03225573
- Acronym / sponsor ID
- CBCT / Rad2:5:1
- Keywords
- second mesiobuccal canal CBCT prevalence population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a cross-sectional study to estimate the prevalence of a second mesiobuccal canal of maxillary first and second molars in Egyptian population using cone beam computed tomography through retrospective data analysis
Detailed description
Setting and Location:
- The data collection will be obtained from the data base available at a private radiographic centre ORASCAN Oral \& Maxillofacial Imaging Centre located in Cairo, Egypt.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2015-16-17.
Participants:
A total of 196 CBCT scans of Maxillary first and second permanent molars belonging to Egyptian individuals will be included.
Variables:
- Number of root canals in mesiobuccal root of first and second maxillary molars
- Sex of the patient will be identified and addressed as the prevalence of the second mesiobuccal canal may show sex predilection
Data Sources / Measurements:
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
All the CBCT examinations were scanned using Cranex® 3D SOREDEX, 0.2 voxel resolution, 8 × 6 cm FOV, 90 kVp, 10 mA and 6 seconds exposure time.
CBCT images will be analysed in the 3 planes; first the sagittal and coronal sections will be oriented parallel to the long axis of the root, and then sections will be obtained on the axial plane for detection of the 2nd mesiobuccal canal.
CBCT images will be interpreted by three oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
Each one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
Then inter-observational and intra-observational variability between the observers will be evaluated.
The sex of the patient will be identified from the patient's demographic data available on the patient's file on the database of the private radiographic centre.
Bias:
No source of bias.
Study Size:
The aim of the study is to assess the prevalence of a second mesiobuccal canal of maxillary first and second molars in Egyptian population. Based on the previous paper by Nikoloudaki et al, 2015, the prevalence of Second Mesiobuccal Canal of Maxillary First and Second Molars was 89 and 85%. Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 196 will be sufficient. The sample size was calculated by Epi info.
Sampling Strategy: The sample will be collected by simple random sampling.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with second mesiobuccal canal will be counted to estimate the prevalence of the second mesiobuccal canal.
Statistical Methods:
- Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between male and females for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
- If the patient's age couldn't be found in the patient's file, the dental age will be used.
- If the patient's sex couldn't be found in the patient's file, the patient's name will be used to indicate the sex. Patients with mixed name will be excluded.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian Population
Key inclusion criteria (4 listed)
- First and second maxillary permanent molars of Egyptian patients starting from 15 years, males or females
- Intact roots without fractures or cracks
- Molars without posts or previous root canal treatment
- CBCT scans of maxillary first and second molars using 8 × 6 Field of view, 0.2 voxel resolution
Key exclusion criteria (10 listed)
- Evidence of apicectomy or periapical surgery
- Odontogenic or non-odontogenic pathology
- Maxillary molars with developmental anomalies
- External or Internal Root resorption
- Canal Calcification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Maxillary Molars With a Second Mesiobuccal Canal
Time frame: 1 month
measuring device is CBCT software On Demand 3D® , measuring unit is binary system (yes/no)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Second Mesiobuccal Canal and Maxillary First and Second Molars, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 11 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Maxillary Molars With a Second Mesiobuccal Canal (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.