Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCTNCT06357156
Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study
An observational study of Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT, run by Cairo University.
Trial summary
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database. Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT
- What is being tested?
- CBCT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Mar 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total sample of 222 mandibular CBCT scans belonging to Egyptian individuals will be included. The sample size will be sub-grouped to 3 age groups per each gender. The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes.
Who may be able to join
- patients' age between (18-75) years, so that the anatomical features of the permanent dentition could be evaluated.
- Mandibular CBCT images with fully or partially edentulous anterior teeth.
- No history or presence of any pathological condition in the mandible
Who cannot join
- Poor image quality
- presence of artifact that impairs the diagnostic quality
- Presence of any pathological condition in the mandible
Trial locations and contacts
No sites are listed yet.
About this study
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.
- The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).
- CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.
- radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.
- The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.
- Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee , Kim et al, 2014).
Read more
Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III
- Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).
After collecting the whole data, statistically will be correlated to the age and gender.
- Being tested
- CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes.
| Study group | Role | What they receive |
|---|---|---|
| males age range 18-35 | Not described Receives: Radiation: CBCT | |
| males age range 36- 55 | Not described Receives: Radiation: CBCT | |
| males age range 56-75 | Not described Receives: Radiation: CBCT | |
| females age range 18-35 | Not described Receives: Radiation: CBCT | |
| females age range 36- 55 | Not described Receives: Radiation: CBCT | |
| females age range 56-75 | Not described Receives: Radiation: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of gender on the mean height of basal bone in the symphysial area
Oblique Reformatted cuts Built-in measuring tool (ruler) (Romexis software) in mm
Measured: 1 year
Secondary outcomes (5)
Effect of gender on quantity of the bone in symphysial area: *depth of the bone *width of the bone
Oblique Reformatted cuts Built-in measuring tool (ruler) (Romexis software) (3D-slicer software) in mm
Measured: 1 year
Effect of gender on topography of the bone in symphysial area
Categorical assessment according to Locks, Bruna Jussara Constantino, et al., 2018 (class I,II or III)/Categorical nominal data (%)
Measured: 1 year
Effect of age on quantity of the bone in the symphysial area
Oblique Reformatted cuts Built-in measuring tool (ruler) (Romexis software) (3D-slicer software) in mm
Measured: 1 year
Effect of age on topography of the bone in symphysial area
Categorical assessment according to Locks, Bruna Jussara Constantino, et al., 2018 (class I,II or III)/Categorical nominal data (%)
Measured: 1 year
Prevalence of mandibular incisive canal
Subjective judge of the radiologist using Oblique Reformatted cuts/present or absent
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCTStudies 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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passant Yusuf Abulabas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357156
- Sponsor's protocol ID
- ORAD-621
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06357156
- Acronym / sponsor ID
- ORAD-621
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.
- The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).
- CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.
- radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.
- The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.
- Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee , Kim et al, 2014).
Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III
- Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).
After collecting the whole data, statistically will be correlated to the age and gender.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| males age range 18-35 | – | Radiation: CBCT |
| males age range 36- 55 | – | Radiation: CBCT |
| males age range 56-75 | – | Radiation: CBCT |
| females age range 18-35 | – | Radiation: CBCT |
| females age range 36- 55 | – | Radiation: CBCT |
| females age range 56-75 | – | Radiation: CBCT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total sample of 222 mandibular CBCT scans belonging to Egyptian individuals will be included. The sample size will be sub-grouped to 3 age groups per each gender. The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes.
Key inclusion criteria (3 listed)
- patients' age between (18-75) years, so that the anatomical features of the permanent dentition could be evaluated.
- Mandibular CBCT images with fully or partially edentulous anterior teeth.
- No history or presence of any pathological condition in the mandible
Key exclusion criteria (3 listed)
- Poor image quality
- presence of artifact that impairs the diagnostic quality
- Presence of any pathological condition in the mandible
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 |
|---|---|---|
| CBCTThe data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial radiology department for different purposes. | Radiation | females age range 18-35, females age range 36- 55, females age range 56-75, males age range 18-35, males age range 36- 55, males age range 56-75 |
Primary outcome
Effect of gender on the mean height of basal bone in the symphysial area
Time frame: 1 year
Oblique Reformatted cuts Built-in measuring tool (ruler) (Romexis software) in mm
5 secondary outcomes
Effect of gender on quantity of the bone in symphysial area: *depth of the bone *width of the bone
Time frame: 1 year
Effect of gender on topography of the bone in symphysial area
Time frame: 1 year
Effect of age on quantity of the bone in the symphysial area
Time frame: 1 year
Effect of age on topography of the bone in symphysial area
Time frame: 1 year
Prevalence of mandibular incisive canal
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT, 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 3 inclusion and 3 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 10 Apr 2024. 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?
Contact Passant Yusuf, masters (01555520970 ext. 02, passant.yusuf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of gender on the mean height of basal bone in the symphysial area (time frame: 1 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 10 Apr 2024.