Sexual DimorphismNCT05907083
Sexual Dimorphism of Sphenoid and Maxillary Air Sinuses Via 3D Volumetric Segmentation of CBCT
An observational study of Sexual Dimorphism and Cone-beam Computed Tomography, run by Cairo University.
Trial summary
Sexual dimorphism from skeletal remains a crucial step towards biological profile reconstruction since these are some of the last structures to remain after death. Paranasal sinuses remain intact even in extreme situations and are able to resist adverse environmental conditions due to their unique properties. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sexual Dimorphism, Cone-beam Computed Tomography, Maxillary Sinus
- What is being tested?
- cone beam computer tomography
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jun 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 20 to 60 years
- All sexes
- Adult
Study population: CBCT maxillofacial scans belonging to Egyptian individuals will be examined
Who may be able to join
- Adult Egyptian patients
- Both sexes of age 20 to 60
- Normal complete upper dental arch
- Normal anatomy of the studied air sinuses.
Who cannot join
- Scans with any facial pathosis like (tumors, odontogenic lesions, and bone lesions).
- Scans showing any skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft.
- Patients with fractures or lesions affecting the studied sinuses.
- Scans with insufficient Field of view
- Scans of low-resolution quality.
- Presence of considerable artifacts.
About this study
Official title: Sexual Dimorphism of Sphenoid and Maxillary Air Sinuses Via 3D Volumetric Segmentation of CBCT: A Cross Sectional Study
Sexual dimorphism from skeletal remains a crucial step towards biological profile reconstruction since these are some of the last structures to remain after death. Paranasal sinuses remain intact even in extreme situations and are able to resist adverse environmental conditions due to their unique properties. The maxillary sinus is the largest of all paranasal sinuses and is considered as characteristic entity like human fingerprints for each person. Also, sphenoid air sinus is located deeply in the skull and is enveloped by different structures inside the sphenoid body. It is the least possibly affected by external deteriorating factors. Owing to limited research on the Egyptian population on the role of 3D volumetric assessment of paranasal sinuses in forensics, this study will be designed to investigate the significance of the volume of both sphenoid and maxillary sinuses in sexual discrimination.
Read the detailed description
Sexual dimorphism from skeletal remains a crucial step towards biological profile reconstruction since these are some of the last structures to remain after death. Paranasal sinuses remain intact even in extreme situations and are able to resist adverse environmental conditions due to their unique properties. The maxillary sinus is the largest of all paranasal sinuses and is considered as characteristic entity like human fingerprints for each person. Also, sphenoid air sinus is located deeply in the skull and is enveloped by different structures inside the sphenoid body. It is the least possibly affected by external deteriorating factors. Owing to limited research on the Egyptian population on the role of 3D volumetric assessment of paranasal sinuses in forensics, this study will be designed to investigate the significance of the volume of both sphenoid and maxillary sinuses in sexual discrimination.
- CBCT Scans included in this study performed using CBCT machine (Planmeca Promax 3D MID (Planmeca OY, Helsinki, Finlan.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Full maxillofacial scans with 0.4 voxel sizes will be reviewed.
- DICOM files of CBCT images will be analysed using Mimics software (version 21.0; Materialize, Leuven, Belgium).
- To measure volumes of the sphenoid and maxillary sinuses, Semiautomatic segmentation will be done using the new mask tool in Mimics software, thresholding will be applied to optimize sinus segmentation.
- The region-growing tool will be used on the previous mask to exclude any data not related to the sinuses and ensure the segmentation precision. Mask calculation will be done and the segmented sinus will be calculated as 3D Volume.
- The volume will be measured in cubic millimeters (mm3) by the software itself.
- The segmentation process will be carried out by one radiologist with 10 years of experience. For inter-observer agreement 50 cases will be segmented again by another radiologist with 15 years of experience in a separate session. Also, the analysis of data will be reviewed by both of them separately.
- CBCT images will be coded and radiologists will be blinded from the age and sex of patients and from the other observers' readings.
- Interpretation will be based mainly on software's segmentation capabilities minimizing the operator's skill dependence.
- Being tested
- cone beam computer tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam computer tomographyRadiation
Also called CBCT
Cone Beam CT Radiation
| Study group | Role | What they receive |
|---|---|---|
| Adult CBCT Scan | CBCT Radiation Receives: Radiation: cone beam computer tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual dimorphism of maxillary air sinuses via volumetric segmentation
Measured: 1 year
Secondary outcomes (2)
Sexual dimorphism of Sphenoid sinuses via volumetric segmentation
Measured: 1 year
Determination of age via sphenoid and maxillary air sinuses volumetric segmentation
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 posted18 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DimorphismStudies 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Samir Ali Abuelola, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907083
- Sponsor's protocol ID
- ORAD7 -1 -1
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dimorphism of Sphenoid and Maxillary Air Sinuses Via 3D Volumetric Segmentation of CBCT: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05907083
- Acronym / sponsor ID
- ORAD7 -1 -1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 18 Jun 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.
Sexual dimorphism from skeletal remains a crucial step towards biological profile reconstruction since these are some of the last structures to remain after death. Paranasal sinuses remain intact even in extreme situations and are able to resist adverse environmental conditions due to their unique properties. The maxillary sinus is the largest of all paranasal sinuses and is considered as characteristic entity like human fingerprints for each person. Also, sphenoid air sinus is located deeply in the skull and is enveloped by different structures inside the sphenoid body. It is the least possibly affected by external deteriorating factors. Owing to limited research on the Egyptian population on the role of 3D volumetric assessment of paranasal sinuses in forensics, this study will be designed to investigate the significance of the volume of both sphenoid and maxillary sinuses in sexual discrimination.
Detailed description
Sexual dimorphism from skeletal remains a crucial step towards biological profile reconstruction since these are some of the last structures to remain after death. Paranasal sinuses remain intact even in extreme situations and are able to resist adverse environmental conditions due to their unique properties. The maxillary sinus is the largest of all paranasal sinuses and is considered as characteristic entity like human fingerprints for each person. Also, sphenoid air sinus is located deeply in the skull and is enveloped by different structures inside the sphenoid body. It is the least possibly affected by external deteriorating factors. Owing to limited research on the Egyptian population on the role of 3D volumetric assessment of paranasal sinuses in forensics, this study will be designed to investigate the significance of the volume of both sphenoid and maxillary sinuses in sexual discrimination.
- CBCT Scans included in this study performed using CBCT machine (Planmeca Promax 3D MID (Planmeca OY, Helsinki, Finlan.
- Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
- Full maxillofacial scans with 0.4 voxel sizes will be reviewed.
- DICOM files of CBCT images will be analysed using Mimics software (version 21.0; Materialize, Leuven, Belgium).
- To measure volumes of the sphenoid and maxillary sinuses, Semiautomatic segmentation will be done using the new mask tool in Mimics software, thresholding will be applied to optimize sinus segmentation.
- The region-growing tool will be used on the previous mask to exclude any data not related to the sinuses and ensure the segmentation precision. Mask calculation will be done and the segmented sinus will be calculated as 3D Volume.
- The volume will be measured in cubic millimeters (mm3) by the software itself.
- The segmentation process will be carried out by one radiologist with 10 years of experience. For inter-observer agreement 50 cases will be segmented again by another radiologist with 15 years of experience in a separate session. Also, the analysis of data will be reviewed by both of them separately.
- CBCT images will be coded and radiologists will be blinded from the age and sex of patients and from the other observers' readings.
- Interpretation will be based mainly on software's segmentation capabilities minimizing the operator's skill dependence.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult CBCT Scan | – | Radiation: cone beam computer tomographyCBCT Radiation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- CBCT maxillofacial scans belonging to Egyptian individuals will be examined
Key inclusion criteria (4 listed)
- Adult Egyptian patients
- Both sexes of age 20 to 60
- Normal complete upper dental arch
- Normal anatomy of the studied air sinuses.
Key exclusion criteria (6 listed)
- Scans with any facial pathosis like (tumors, odontogenic lesions, and bone lesions).
- Scans showing any skeletal asymmetries, craniofacial traumas and developmental anomalies such as palatal cleft.
- Patients with fractures or lesions affecting the studied sinuses.
- Scans with insufficient Field of view
- Scans 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 |
|---|---|---|
| cone beam computer tomographyAlso: CBCTCone Beam CT Radiation | Radiation | Adult CBCT Scan |
Primary outcome
Sexual dimorphism of maxillary air sinuses via volumetric segmentation
Time frame: 1 year
2 secondary outcomes
Sexual dimorphism of Sphenoid sinuses via volumetric segmentation
Time frame: 1 year
Determination of age via sphenoid and maxillary air sinuses volumetric segmentation
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 18 Jun 2023.
Related trials for Sexual Dimorphism
RecruitingPhase 1
Sex Differences in the Response to Abstinence From Alcohol.
Alcohol Use Disorder
Recruiting
Sex Differences in BDNF Study
Exercise, BDNF
Not yet recruitingEarly Phase 1
Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome
Metabolic Syndrome
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Recruiting
Sex Differences in Metabolism Following a High-fat Meal
Healthy Nutrition
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 Sexual Dimorphism and Cone-beam Computed Tomography, 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 4 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 18 Jun 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?
Sexual dimorphism of maxillary air sinuses via volumetric segmentation (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 18 Jun 2023.