Morphology of Maxillary Premolars in Egyptian SubpopulationNCT03563508
A Cone-beam Computed Tomography Study of Root and Root Canal Morphology of Maxillary Premolars in an Egyptian Subpopulation
An observational study of Morphology of Maxillary Premolars in Egyptian Subpopulation, run by Cairo University at 1 site in Egypt.
Trial summary
to date there is no detailed examination of the root and root canal system of maxillary first and second premolars in an Egyptian subpopulation. in this study the investigators do an Observational analysis of available records of cone-beam computed tomography (CBCT) of root and canal morphology in the permanent… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Morphology of Maxillary Premolars in Egyptian Subpopulation
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Jul 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: • CBCT of a sample of Egyptian subpopulation in Cairo governorate
Who may be able to join
- CBCT scans with minimum of one premolar.
- Maxillary premolars with fully formed apices
Who cannot join
- CBCT scans with all maxillary premolars missed.
- Maxillary premolars with open apices
- Maxillary premolars with root resorption
- Maxillary premolars with calcifications or extensive coronal restoration.
- Maxillary premolars with root canal fillings, posts, crown restorations.
Trial locations and contacts
1 site in 1 country.
About this study
to date there is no detailed examination of the root and root canal system of maxillary first and second premolars in an Egyptian subpopulation. in this study the investigators do an Observational analysis of available records of cone-beam computed tomography (CBCT) of root and canal morphology in the permanent maxillary first and second premolars in this population
Read the detailed description
Failure of endodontic treatment of upper first and second premolar because of presence of missed canals with lack of data of its morphological variations in the Egyptian population.There are different methods to study canal morphology as tooth clearing and root canal staining, conventional and digital radiographs, radiographic assessment enhanced with contrast media. Recently cone-beam computed tomographic (CBCT) images have been found to be useful in providing accurate anatomic details in 3 dimensions for diagnosis and treatment planning before endodontic therapy.
in this study the investigators do an Observational analysis of available records of cone-beam computed tomography (CBCT) of root and canal morphology in the permanent maxillary first and second premolars in this population
- Keywords
- cone beam computed tomography, maxillary premolars, root canal anatomy, root canal morphology, Egyptian population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CBCT of Egyptian subpopulation | Cone-beam computed tomography (CBCT) of a sample of Egyptian subpopulation containing maxillary premolars for image assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
root numbers in maxillary first and second premolars
root
Measured: year
Secondary outcomes (2)
Number of canals per root
root canal
Measured: year
Type of root canal
Categorical data
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morphology of Maxillary Premolars in Egyptian SubpopulationStudies 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
- Cross-sectional
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maysa mostafa Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563508
- Sponsor's protocol ID
- cebd-cu-2018-05-31
- Status last verified
- May 2018
- First submitted
- 30 May 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Cone-beam computed tomography study of root and root canal morphology of maxillary premolars in an Egyptian subpopulation
Publications
Abella F, Teixido LM, Patel S, Sosa F, Duran-Sindreu F, Roig M. Cone-beam Computed Tomography Analysis of the Root Canal Morphology of Maxillary First and Second Premolars in a Spanish Population. J Endod. 2015 Aug;41(8):1241-7. doi: 10.1016/j.joen.2015.03.026. Epub 2015 May 5.
PubMed 25956606Celikten B, Orhan K, Aksoy U, Tufenkci P, Kalender A, Basmaci F, Dabaj P. Cone-beam CT evaluation of root canal morphology of maxillary and mandibular premolars in a Turkish Cypriot population. BDJ Open. 2016 Jan 29;2:15006. doi: 10.1038/bdjopen.2015.6. eCollection 2016.
PubMed 29607060Tian YY, Guo B, Zhang R, Yu X, Wang H, Hu T, Dummer PM. Root and canal morphology of maxillary first premolars in a Chinese subpopulation evaluated using cone-beam computed tomography. Int Endod J. 2012 Nov;45(11):996-1003. doi: 10.1111/j.1365-2591.2012.02059.x. Epub 2012 May 2.
PubMed 22551454
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cone-beam Computed Tomography Study of Root and Root Canal Morphology of Maxillary Premolars in an Egyptian Subpopulation
- ClinicalTrials.gov ID
- NCT03563508
- Acronym / sponsor ID
- cebd-cu-2018-05-31
- Keywords
- cone beam computed tomography, maxillary premolars, root canal anatomy, root canal morphology, Egyptian population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Jun 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.
to date there is no detailed examination of the root and root canal system of maxillary first and second premolars in an Egyptian subpopulation. in this study the investigators do an Observational analysis of available records of cone-beam computed tomography (CBCT) of root and canal morphology in the permanent maxillary first and second premolars in this population
Detailed description
Failure of endodontic treatment of upper first and second premolar because of presence of missed canals with lack of data of its morphological variations in the Egyptian population.There are different methods to study canal morphology as tooth clearing and root canal staining, conventional and digital radiographs, radiographic assessment enhanced with contrast media. Recently cone-beam computed tomographic (CBCT) images have been found to be useful in providing accurate anatomic details in 3 dimensions for diagnosis and treatment planning before endodontic therapy.
in this study the investigators do an Observational analysis of available records of cone-beam computed tomography (CBCT) of root and canal morphology in the permanent maxillary first and second premolars in this population
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT of Egyptian subpopulation | – | –Cone-beam computed tomography (CBCT) of a sample of Egyptian subpopulation containing maxillary premolars for image assessment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- • CBCT of a sample of Egyptian subpopulation in Cairo governorate
Key inclusion criteria (2 listed)
- CBCT scans with minimum of one premolar.
- Maxillary premolars with fully formed apices
Key exclusion criteria (5 listed)
- CBCT scans with all maxillary premolars missed.
- Maxillary premolars with open apices
- Maxillary premolars with root resorption
- Maxillary premolars with calcifications or extensive coronal restoration.
- Maxillary premolars with root canal fillings, posts, crown restorations.
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
root numbers in maxillary first and second premolars
Time frame: year
root
2 secondary outcomes
Number of canals per root
Time frame: year
Type of root canal
Time frame: year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Background: PubMed 25956606Abella F, Teixido LM, Patel S, Sosa F, Duran-Sindreu F, Roig M. Cone-beam Computed Tomography Analysis of the Root Canal Morphology of Maxillary First and Second Premolars in a Spanish Population. J Endod. 2015 Aug;41(8):1241-7. doi: 10.1016/j.joen.2015.03.026. Epub 2015 May 5.
- Background: PubMed 29607060Celikten B, Orhan K, Aksoy U, Tufenkci P, Kalender A, Basmaci F, Dabaj P. Cone-beam CT evaluation of root canal morphology of maxillary and mandibular premolars in a Turkish Cypriot population. BDJ Open. 2016 Jan 29;2:15006. doi: 10.1038/bdjopen.2015.6. eCollection 2016.
- Background: PubMed 22551454Tian YY, Guo B, Zhang R, Yu X, Wang H, Hu T, Dummer PM. Root and canal morphology of maxillary first premolars in a Chinese subpopulation evaluated using cone-beam computed tomography. Int Endod J. 2012 Nov;45(11):996-1003. doi: 10.1111/j.1365-2591.2012.02059.x. Epub 2012 May 2.
- Individual participant dataSharing planned: No. A Cone-beam computed tomography study of root and root canal morphology of maxillary premolars in an Egyptian subpopulation
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 Morphology of Maxillary Premolars in Egyptian Subpopulation, 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 5 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 21 Jun 2018. 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 maysa mo ahmed, B.D.S (0020108032614, maysa.mostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
root numbers in maxillary first and second premolars (time frame: year). 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 NCT03563508, which also lists 3 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 21 Jun 2018.