Prevalence of Curvatures in Root CanalsNCT04555070
Assessment of Root Canal Curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population Using CBCT
An observational study of Prevalence of Curvatures in Root Canals and Direction of Curvatures in Root Canals, run by Cairo University.
Trial summary
A cross-sectional study to assess variations in root canal curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population using cone beam computed tomography through retrospective data analysis Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Prevalence of Curvatures in Root Canals, Direction of Curvatures in Root Canals, Severity of Curvatures in Root Canals
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Oct 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Egyptian population
Who may be able to join
- CBCT scans should show
- Fully maturated and erupted mandibular permanent first and second molars of Egyptian patients above 16 years old.
- Intact molars' roots without fractures or cracks.
- Mandibular permanent first and second molars without posts or previous root canal treatment.
- Full extension of mandibular first and second molars using different fields of view and maximum 0.2 mm voxel resolution will be included
Who cannot join
- • Evidence of apicectomy or peri-apical surgery.
- Mandibular molars with developmental anomalies.
- External or Internal Root resorption.
- Root Canal Calcification.
- Previous Root Canal treatment or posts.
- Presence of Root caries.
- Tomographic images of poor quality or artifacts interfering with the detection of root canals.
About this study
Official title: Assessment of The Direction and Severity of Root Canal Curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population Using CBCT: A Cross-Sectional Study
A cross-sectional study to assess variations in root canal curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population using cone beam computed tomography through retrospective data analysis
Read the detailed description
- Study design and setting
- Study Design: An observational Cross-sectional Study
- Setting and Location: Being a retrospective study, CBCT scans of Egyptian patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning will be included. The CBCT scans will be obtained from the data base available at the department of Oral and Maxillo-facial Radiology, Faculty of Dentistry, Cairo University, and a private Oral Radiology center, Cairo, Egypt.
- Participants:
Based on sample size calculation, a sample of 272 canals of mandibular first and second permanent molars belonging to Egyptian individuals will be examined. The selection of the scans to be included will be based on the following eligibility criteria.
- Variables:
- Details about variable
- Mesio-distal direction of root canal curvatures in the sagittal cuts.
- Bucco-lingual direction of root canal curvatures in the coronal cuts.
- Schneider's angle of root canals curvatures present in both coronal and sagittal cuts.
- Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans were varied depending on the individual patient's sizes.
- CBCT scans showing mandibular first and second permanent molars with maximum 0.2 voxel sizes will be reviewed.
- CBCT images will be analysed using Planmeca Romexis Viewer software, CBCT images will be analyzed in 2 planes; the root canal curvatures in the mesio-distal dimension from the sagittal section and the curvatures in the bucco-lingual dimension from the coronal sections, determining the direction of root canal curvatures.
- For each image of canal trajectory, the number of curvatures and their angle will be recorded using Schneider's criteria (Schneider 1971) as follows; (5 degrees or less); as straight canal (10 to 20 degrees); as moderate curvature (25 to 70 degrees); as severe curvature
- If the trajectory of the canal contained more than one curve, the additional curvatures were measured as described by Cunningham \& Senia (1992) who measured Schneider's angle for each curve.
- All CBCT scans will be interpreted by the main investigator, and 30% of the scans will be re-viewed by the same radiologist to assess intra-observer reliability with at least 2 weeks interval and by another experienced radiologist (co-supervisor) to assess inter-observer reliability.
- Addressing potential sources of bias: No source of bias. CBCT scans will be coded and interpreted by two oral and maxillofacial radiologists blinded from demographic data of the patients and from the results of each other.
- Study Size: This power analysis used percentage of curved canals at the cervical third in sagittal plane as the primary outcome. Based upon the results of Estrela C et al (2015), the percentage was 77%. Using alpha (α) level of (5%), acceptable margin of error = 5%; the minimum estimated sample size was 272 canals. Sample size calculation was performed using Epi Info 7.2.2.2.
- Sampling strategy: The sample will be collected by simple random sampling. H) Quantitative variables
- Handling of quantitative variables in analyses The number of root canals of permanent mandibular first and second molars of Egyptian individuals with root canal curvatures will be counted to estimate the variations in the Egyptian population.
Severity of curvatures will be estimated using Schneider's method. The direction of curvatures will be detected from sagittal and coronal cuts.
- Statistical methods:
*Statistical methods. Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Scienceaszxs), 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. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
- Conditions
- Prevalence of Curvatures in Root Canals, Direction of Curvatures in Root Canals, Severity of Curvatures in Root Canals
- Keywords
- Mandibular molars, Root canal curvature, Root canal complexity, CBCT
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of root canal curvatures in cervical third of roots in mandibular first and second molars
Measured: one year
Secondary outcomes (1)
prevalence of root canal curvatures in middle third of roots in mandibular first and second molars
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Curvatures in Root CanalsStudies 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
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Medhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555070
- Sponsor's protocol ID
- ORAD7:1:1
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of The Direction and Severity of Root Canal Curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population Using CBCT: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04555070
- Acronym / sponsor ID
- ORAD7:1:1
- Conditions
- Prevalence of Curvatures in Root Canals, Direction of Curvatures in Root Canals, Severity of Curvatures in Root Canals
- Keywords
- Mandibular molars, Root canal curvature, Root canal complexity, CBCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 18 Sep 2020 (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.
A cross-sectional study to assess variations in root canal curvatures of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population using cone beam computed tomography through retrospective data analysis
Detailed description
- Study design and setting
- Study Design: An observational Cross-sectional Study
- Setting and Location: Being a retrospective study, CBCT scans of Egyptian patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning will be included. The CBCT scans will be obtained from the data base available at the department of Oral and Maxillo-facial Radiology, Faculty of Dentistry, Cairo University, and a private Oral Radiology center, Cairo, Egypt.
- Participants:
Based on sample size calculation, a sample of 272 canals of mandibular first and second permanent molars belonging to Egyptian individuals will be examined. The selection of the scans to be included will be based on the following eligibility criteria.
- Variables:
- Details about variable
- Mesio-distal direction of root canal curvatures in the sagittal cuts.
- Bucco-lingual direction of root canal curvatures in the coronal cuts.
- Schneider's angle of root canals curvatures present in both coronal and sagittal cuts.
- Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans were varied depending on the individual patient's sizes.
- CBCT scans showing mandibular first and second permanent molars with maximum 0.2 voxel sizes will be reviewed.
- CBCT images will be analysed using Planmeca Romexis Viewer software, CBCT images will be analyzed in 2 planes; the root canal curvatures in the mesio-distal dimension from the sagittal section and the curvatures in the bucco-lingual dimension from the coronal sections, determining the direction of root canal curvatures.
- For each image of canal trajectory, the number of curvatures and their angle will be recorded using Schneider's criteria (Schneider 1971) as follows; (5 degrees or less); as straight canal (10 to 20 degrees); as moderate curvature (25 to 70 degrees); as severe curvature
- If the trajectory of the canal contained more than one curve, the additional curvatures were measured as described by Cunningham \& Senia (1992) who measured Schneider's angle for each curve.
- All CBCT scans will be interpreted by the main investigator, and 30% of the scans will be re-viewed by the same radiologist to assess intra-observer reliability with at least 2 weeks interval and by another experienced radiologist (co-supervisor) to assess inter-observer reliability.
- Addressing potential sources of bias: No source of bias. CBCT scans will be coded and interpreted by two oral and maxillofacial radiologists blinded from demographic data of the patients and from the results of each other.
- Study Size: This power analysis used percentage of curved canals at the cervical third in sagittal plane as the primary outcome. Based upon the results of Estrela C et al (2015), the percentage was 77%. Using alpha (α) level of (5%), acceptable margin of error = 5%; the minimum estimated sample size was 272 canals. Sample size calculation was performed using Epi Info 7.2.2.2.
- Sampling strategy: The sample will be collected by simple random sampling. H) Quantitative variables
- Handling of quantitative variables in analyses The number of root canals of permanent mandibular first and second molars of Egyptian individuals with root canal curvatures will be counted to estimate the variations in the Egyptian population.
Severity of curvatures will be estimated using Schneider's method. The direction of curvatures will be detected from sagittal and coronal cuts.
- Statistical methods:
*Statistical methods. Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Scienceaszxs), 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. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian population
Key inclusion criteria (5 listed)
- CBCT scans should show
Key exclusion criteria (7 listed)
- • Evidence of apicectomy or peri-apical surgery.
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
prevalence of root canal curvatures in cervical third of roots in mandibular first and second molars
Time frame: one year
1 secondary outcome
prevalence of root canal curvatures in middle third of roots in mandibular first and second molars
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence of Curvatures in Root Canals and Direction of Curvatures in Root Canals, run by Cairo University.
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 5 inclusion and 7 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
prevalence of root canal curvatures in cervical third of roots in mandibular first and second molars (time frame: one year). 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 18 Sep 2020.