Sinus VolumeNCT04092699
CBCT Segmentation in Volumetric Measurements of MS Using Different Soft Wares: A Validity and Reliability Study
A study testing semiautomatic software in people with Sinus Volume and CBCT Segmentation, run by Cairo University.
Trial summary
Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sinus Volume, CBCT Segmentation
- What is being tested?
- semiautomatic software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Sep 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
- Inclusion Criteria of participants of the In vitro part of the study:
- Skulls with intact walls of maxillary sinus.
- Skulls with dentulous or edentulous jaws.
Who cannot join
- Skulls with missing parts of the maxilla that could be caused from traumatic injuries, diseases and space occupying lesions of maxilla.
- Skulls with severe mutilation caused by environmental decay.
- Inclusion Criteria of participants of the In vivo part of the study:
- Patients without any pathosis affects maxillary sinus.
- Patients with dentulous or edentulous jaws.
- Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
- Patients with sinus lifting or surgeries.
- Patients with mucosal thickening more than 3mm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cone Beam Computed Tomographic Segmentation in Volumetric Measurements of Maxillary Sinus Using Different Soft Wares: A Validity and Reliability Study
Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Regarding the semi-automatic segmentation, there are researches assessed the volumetric measurement of the maxillary sinus and they reported that there is no significant difference between semi- automatic and the manual segmentation in CT.
Read the detailed description
Automatic segmentation is believed to be less time consuming and more accurate in assessment of structures with regular border but fairly assessed the structures with irregular border like paranasal sinuses. The semi-automatic software is efficient and accurate as manual tracing with significant reduction in inter-observer variability and time . On the other hand, all neighboring contacting voxels located within a defined range (threshold) of similar HU values of different adjacent tissues may be measured so over calculation or under calculation could be suspected
- Conditions
- Sinus Volume, CBCT Segmentation
- Being tested
- semiautomatic software
- Keywords
- CBCT, maxillary sinus, segmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semiautomatic softwareDevice
Also called Mimics medical 19., Romexis, On Demand 3D
semiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation.
| Study group | Role | What they receive |
|---|---|---|
| patient | Other | CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software Receives: Device: semiautomatic software |
| skulls | Other | CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software Receives: Device: semiautomatic software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus.
validity and reliability
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 posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Sep 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 Sinus VolumeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ashraf Hussien, Cairo University
- Investigators
- Reham Ashraf, master, Principal investigator, Reham Ashraf Hussien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092699
- Sponsor's protocol ID
- Dentistry
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berberi A, Bouserhal L, Nader N, Assaf RB, Nassif NB, Bouserhal J, Salameh Z. Evaluation of Three-Dimensional Volumetric Changes After Sinus Floor Augmentation with Mineralized Cortical Bone Allograft. J Maxillofac Oral Surg. 2015 Sep;14(3):624-9. doi: 10.1007/s12663-014-0736-3. Epub 2014 Dec 24.
PubMed 26225054Alsufyani NA, Flores-Mir C, Major PW. Three-dimensional segmentation of the upper airway using cone beam CT: a systematic review. Dentomaxillofac Radiol. 2012 May;41(4):276-84. doi: 10.1259/dmfr/79433138.
PubMed 22517995El H, Palomo JM. Measuring the airway in 3 dimensions: a reliability and accuracy study. Am J Orthod Dentofacial Orthop. 2010 Apr;137(4 Suppl):S50.e1-9; discussion S50-2. doi: 10.1016/j.ajodo.2010.01.014.
PubMed 20381759
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam Computed Tomographic Segmentation in Volumetric Measurements of Maxillary Sinus Using Different Soft Wares: A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT04092699
- Acronym / sponsor ID
- Dentistry
- Conditions
- Sinus Volume, CBCT Segmentation
- Keywords
- CBCT, maxillary sinus, segmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 17 Sep 2019 (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.
Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Regarding the semi-automatic segmentation, there are researches assessed the volumetric measurement of the maxillary sinus and they reported that there is no significant difference between semi- automatic and the manual segmentation in CT.
Detailed description
Automatic segmentation is believed to be less time consuming and more accurate in assessment of structures with regular border but fairly assessed the structures with irregular border like paranasal sinuses. The semi-automatic software is efficient and accurate as manual tracing with significant reduction in inter-observer variability and time . On the other hand, all neighboring contacting voxels located within a defined range (threshold) of similar HU values of different adjacent tissues may be measured so over calculation or under calculation could be suspected
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Other | Device: semiautomatic softwareCBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software |
| skulls | Other | Device: semiautomatic softwareCBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- -
- Skulls with intact walls of maxillary sinus.
- Skulls with dentulous or edentulous jaws.
Key exclusion criteria (8 listed)
- Skulls with missing parts of the maxilla that could be caused from traumatic injuries, diseases and space occupying lesions of maxilla.
- Skulls with severe mutilation caused by environmental decay.
- Patients without any pathosis affects maxillary sinus.
- Patients with dentulous or edentulous jaws.
- Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
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 |
|---|---|---|
| semiautomatic softwareAlso: Mimics medical 19., Romexis, On Demand 3Dsemiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation. | Device | patient, skulls |
Primary outcome
Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus.
Time frame: 1 year
validity and reliability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Results publication: PubMed 26225054Berberi A, Bouserhal L, Nader N, Assaf RB, Nassif NB, Bouserhal J, Salameh Z. Evaluation of Three-Dimensional Volumetric Changes After Sinus Floor Augmentation with Mineralized Cortical Bone Allograft. J Maxillofac Oral Surg. 2015 Sep;14(3):624-9. doi: 10.1007/s12663-014-0736-3. Epub 2014 Dec 24.
- Results publication: PubMed 22517995Alsufyani NA, Flores-Mir C, Major PW. Three-dimensional segmentation of the upper airway using cone beam CT: a systematic review. Dentomaxillofac Radiol. 2012 May;41(4):276-84. doi: 10.1259/dmfr/79433138.
- Results publication: PubMed 20381759El H, Palomo JM. Measuring the airway in 3 dimensions: a reliability and accuracy study. Am J Orthod Dentofacial Orthop. 2010 Apr;137(4 Suppl):S50.e1-9; discussion S50-2. doi: 10.1016/j.ajodo.2010.01.014.
- Individual participant dataSharing planned: Undecided
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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.
Reham Ashraf, master principal investigator
Reham Ashraf Hussien
Questions about this trial
What is this clinical trial studying?
A study testing semiautomatic software in people with Sinus Volume and CBCT Segmentation, 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 8 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 17 Sep 2019. 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 Reham Ashraf, master (01027518071 ext. 01027518071, reham.ashraf87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus. (time frame: 1 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 NCT04092699, 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 17 Sep 2019.