Analyzing second molar configuration in a Syrian population using 3D radiograph
| ISRCTN | ISRCTN11938034 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11938034 |
| Secondary identifying numbers | 3238 |
- Submission date
- 05/06/2024
- Registration date
- 14/06/2024
- Last edited
- 05/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Root canal treatment (endodontics) is a dental procedure that treats infection at the centre of a tooth. Successful endodontic treatments require a comprehensive knowledge of the root canal anatomy, so the aim of this study was to investigate the root number and morphology of the maxillary second molars (back teeth on the upper jaw) in Syrian patients.
Who can participate?
Patients aged between 15 and 65 years who had cone beam computed tomography (CBCT) scan images taken for orthodontic or surgical reasons Damascus University Faculty of Dentistry from November 2020 to January 2022
What does the study involve?
The CBCT images were examined by two endodontists. The detailed analysis included the number of roots, the number of canals and their configurations, bilateral symmetry, and relation to gender.
What are the possible benefits and risks of participating?
This study could improve our understanding of root canal anatomy and improve the outcomes of endodontic treatment. There are no risks as the patients are not exposed to radiation (for the CBCT scan) because of this study but rather because of other orthodontic or surgical reasons.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
September 2020 to January 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Safaa Allawi, safaa94.allawi@damascusuniversity.edu.sy, d.safaa.elawi@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh
Damascus
22743
Syria
 ORCID ID |
0000-0002-5436-5297 |
|---|---|
| Phone | +963 (0)994219751 |
| d.safaa.elawi@gmail.com |
Study information
| Study design | Observational epidemiological study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Cone beam computed tomography analysis of the root and canal morphology of the maxillary second molars in a Syrian subpopulation |
| Study objectives | A χ2 test was used to assess left and right maxillary second molar symmetry in males and females |
| Ethics approval(s) |
1. Approved 11/11/2020, Research Ethics Committee of the Faculty of Dentistry (Damascus University, Damascus, 22743, Syria; -; president@damasuniv.edu.sy), ref: 0932114205 2. Approved 11/11/2020, Research Ethics Committee of the Faculty of Dentistry (Damascus University, Damascus, 22743, Syria; +963 (0)932114205; mouhmmad9.altayyan@damascusuniversity.edu.sy), ref: 0944231399 |
| Health condition(s) or problem(s) studied | The number of roots and configuration of the root canals of maxillary second molars across various levels (axial, coronal, sagittal, oblique, and 3D) |
| Intervention | Two experienced Endodontics performed image evaluation and data analysis of 250 CBCT images containing 500 maxillary second molars in patients aged between 15 and 65 years. Subsequently, a third dental specialist researcher randomly reviewed 10% of the sample. The study investigated the number of roots and configuration of the root canals of maxillary second molars across various levels (axial, coronal, sagittal, oblique, and 3D). |
| Intervention type | Other |
| Primary outcome measure | Number of roots in maxillary second molars and root canal configuration, recorded after being observed visually by two experienced Endodontics who performed CBCT image evaluation and data analysis across various levels (axial, coronal, sagittal, oblique, and 3D). Measured at a single timepoint for each patient and two experienced endodontics examined the CBCT images again 2 months later to ensure the accuracy of the recorded results. |
| Secondary outcome measures | The symmetry of the number of roots in maxillary second molars and symmetry in the numbers and configuration of the root canal, recorded after being observed visually by two experienced Endodontics who performed CBCT image evaluation and data analysis across various levels (axial, coronal, sagittal, oblique, and 3D). Measured at a single timepoint for each patient and two experienced endodontics examined the CBCT images again 2 months later to ensure the accuracy of the recorded results. |
| Overall study start date | 01/09/2020 |
| Completion date | 12/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 250 |
| Key inclusion criteria | 1. 250 CBCT images containing 500 maxillary second molars of patients aged between 15 and 65 years 2. Specified fully erupted maxillary second molars on both right and left sides 3. Possessing complete roots with a closed apex |
| Key exclusion criteria | 1. Root resorption (internal or external) 2. Apical lesions 3. Post and core 4. Calcified canals 5. Previous endodontic treatment 6. Teeth presented with dental malformations |
| Date of first enrolment | 11/11/2020 |
| Date of final enrolment | 12/01/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
22743
Syria
Sponsor information
University/education
Faculty of Dentistry
Damascus
22743
Syria
| Phone | +963 (0)932114205 |
|---|---|
| dl.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 08/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication |
Editorial Notes
05/08/2024: The study contact was updated
12/06/2024: Study's existence confirmed by the Damascus University.
