Cone-beam Computed TomographyNCT05847777
Correlation Between Maxillary Sinus (Linear and Volumetric Measurements) and Midface Width Using CBCT
An observational study of Cone-beam Computed Tomography and Maxillary Sinus, run by Cairo University.
Trial summary
The objective of this study will be To assess the correlation of the 2-D and volumetric maxillary sinus dimensions with the linear measurement of the mid-face width in adult Egyptian individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cone-beam Computed Tomography, Maxillary Sinus, Midface
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 May 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 50 years
- All sexes
- Adult
Study population: CBCT maxillofacial scans belonging to Egyptian individuals will be examined
Who may be able to join
- CBCT scans of adult Egyptian patients, males and females, with age range between 18 and 50 years old. Patients will be divided into two age groups (group 1 less than or equal 30 years old, group2 more than 30 years old).
- CBCT scans of patient without previous orthodontic treatment.
- CBCT scans without any other treatment that might interfere with the natural course of maxillomandibular growth and development.
Who cannot join
- Scans with maxillary pathologies like (tumors, odontogenic lesions, bone lesions).
- Patients with traumatic injuries or fractures affecting the maxillary sinus.
- Patients with missing upper premolar or molar teeth in one side or both sides.
- Patients with skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft.
- Images of low-resolution quality.
- Distortion of images or presence of any artifacts.
About this study
Official title: Correlation Between Maxillary Sinus (Linear and Volumetric Measurements) and Midface Width Using CBCT A Cross Sectional Study
The objective of this study will be To assess the correlation of the 2-D and volumetric maxillary sinus dimensions with the linear measurement of the mid-face width in adult Egyptian individuals. 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. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and volumetric measurements will be assessed for each sinus. Also the width of midface will be assessed.
Read the detailed description
The objective of this study will be To assess the correlation of the 2-D and volumetric maxillary sinus dimensions with the linear measurement of the mid-face width in adult Egyptian individuals. 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. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and volumetric measurements will be assessed for each sinus. Also the width of midface will be assessed.
CBCT images will be analysed using Mimics software (version 21.0; Materialise, Leuven, Belgium). To measure volumes of the maxillary sinuses, thresholding will be applied with minimum and maximum limits of - 1024 HU and - 526 HU, respectively. The maxillary sinus will be cropped using the software's "edit masks" tool along the following borders: around the bone structure and narrowest space of the ostium between the infundibulum and the uncinate process After this, three-dimensional (3D) models of the sinuses will be created and the volumes of the right and left sinuses will be calculated separately by giving different colors to the sinuses of the same patient.
Slice thickness will be maintained at 0.4 mm as a standard for further 2-D and 3-D reconstruction.
All maxillary sinus measurements will be performed separately on the left and right sides.
For the maxillary sinus linear 2D measurements, each scan will be assessed for:
Maximal vertical diameter (maximal height) of the maxillary sinus (MSH) involves the longest distance from the lowest point of the inferior wall to the highest point of the superior wall in the adjusted sagittal image.
Maximal horizontal diameter (maximal width) of the maxillary sinus (MSW) involves the longest distance perpendicular from the most prominent point of the medial wall to the most prominent point of the lateral wall on the adjusted axial image.
Maximal anteroposterior diameter (maximal length) of the maxillary sinus (MSL) involves the longest distance from the most anterior point of the anterior wall to the most posterior point of the posterior wall on the adjusted the axial image.
To measure the midface width on CBCT adjusted coronal image, the most lateral and inferior point of the maxillozygomatic suture (zm point) on both sides will be detected and measure the distance between them.
To measure one side maxillary width, the distance between (zm point) of one side to mid palatine will be recorded.
- Being tested
- CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
cone beam computer tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Maxillary sinus linear measurements with width of midface
Measured: 1 year
Correlation between Maxillary sinus volumetric measurements with width of midface
Measured: 1 year
Secondary outcomes (3)
Correlation between Maxillary sinus volumetric measurement with mandibular body length
Measured: 1 year
Maxillary sinus volume dimensions with age variables
Measured: 1 year
Maxillary sinus volume dimensions with sex variables
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 posted8 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cone-beam Computed TomographyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ahmed Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847777
- Sponsor's protocol ID
- ORAD3 -3 -1
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Maxillary Sinus (Linear and Volumetric Measurements) and Midface Width Using CBCT A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05847777
- Acronym / sponsor ID
- ORAD3 -3 -1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 8 May 2023 (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.
The objective of this study will be To assess the correlation of the 2-D and volumetric maxillary sinus dimensions with the linear measurement of the mid-face width in adult Egyptian individuals. 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. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and volumetric measurements will be assessed for each sinus. Also the width of midface will be assessed.
Detailed description
The objective of this study will be To assess the correlation of the 2-D and volumetric maxillary sinus dimensions with the linear measurement of the mid-face width in adult Egyptian individuals. 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. The following radiographic examination will be done in Oral and Maxillofacial Radiology Department, Faculty Dentistry, Cairo University. semiautomated segmentation will be performed for the maxillary sinus in both side and then linear and volumetric measurements will be assessed for each sinus. Also the width of midface will be assessed.
CBCT images will be analysed using Mimics software (version 21.0; Materialise, Leuven, Belgium). To measure volumes of the maxillary sinuses, thresholding will be applied with minimum and maximum limits of - 1024 HU and - 526 HU, respectively. The maxillary sinus will be cropped using the software's "edit masks" tool along the following borders: around the bone structure and narrowest space of the ostium between the infundibulum and the uncinate process After this, three-dimensional (3D) models of the sinuses will be created and the volumes of the right and left sinuses will be calculated separately by giving different colors to the sinuses of the same patient.
Slice thickness will be maintained at 0.4 mm as a standard for further 2-D and 3-D reconstruction.
All maxillary sinus measurements will be performed separately on the left and right sides.
For the maxillary sinus linear 2D measurements, each scan will be assessed for:
Maximal vertical diameter (maximal height) of the maxillary sinus (MSH) involves the longest distance from the lowest point of the inferior wall to the highest point of the superior wall in the adjusted sagittal image.
Maximal horizontal diameter (maximal width) of the maxillary sinus (MSW) involves the longest distance perpendicular from the most prominent point of the medial wall to the most prominent point of the lateral wall on the adjusted axial image.
Maximal anteroposterior diameter (maximal length) of the maxillary sinus (MSL) involves the longest distance from the most anterior point of the anterior wall to the most posterior point of the posterior wall on the adjusted the axial image.
To measure the midface width on CBCT adjusted coronal image, the most lateral and inferior point of the maxillozygomatic suture (zm point) on both sides will be detected and measure the distance between them.
To measure one side maxillary width, the distance between (zm point) of one side to mid palatine will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- CBCT maxillofacial scans belonging to Egyptian individuals will be examined
Key inclusion criteria (3 listed)
- CBCT scans of adult Egyptian patients, males and females, with age range between 18 and 50 years old. Patients will be divided into two age groups (group 1 less than or equal 30 years old, group2 more than 30 years old).
- CBCT scans of patient without previous orthodontic treatment.
- CBCT scans without any other treatment that might interfere with the natural course of maxillomandibular growth and development.
Key exclusion criteria (6 listed)
- Scans with maxillary pathologies like (tumors, odontogenic lesions, bone lesions).
- Patients with traumatic injuries or fractures affecting the maxillary sinus.
- Patients with missing upper premolar or molar teeth in one side or both sides.
- Patients with skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft.
- Images of low-resolution quality.
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 |
|---|---|---|
| CBCTcone beam computer tomography | Radiation | – |
Primary outcome
Correlation between Maxillary sinus linear measurements with width of midface
Time frame: 1 year
Correlation between Maxillary sinus volumetric measurements with width of midface
Time frame: 1 year
3 secondary outcomes
Correlation between Maxillary sinus volumetric measurement with mandibular body length
Time frame: 1 year
Maxillary sinus volume dimensions with age variables
Time frame: 1 year
Maxillary sinus volume dimensions with sex variables
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 8 May 2023.
- Related InfoLink provided by the sponsor.
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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 Cone-beam Computed Tomography and Maxillary Sinus, 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 6 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 8 May 2023. 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?
Correlation between Maxillary sinus linear measurements with width of midface (time frame: 1 year). The study lists 2 primary outcomes in all. 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 8 May 2023.